Pilot and Feasibility Studies最新文献

{"title":"Feasibility and acceptability of a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appearance.","authors":"Nichole R Kelly, Kelly Jean Doty, Bonnie H C Schrag, Shaylah Bryant, Sammy Plezia, Nicholas J Parr, Elizabeth L Budd","doi":"10.1186/s40814-025-01630-8","DOIUrl":"https://doi.org/10.1186/s40814-025-01630-8","url":null,"abstract":"<p><strong>Background: </strong>Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common and associated with depression and disordered eating. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling and bringing support into distressing memories, like NEREAs. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The primary objectives of this pilot trial were to evaluate the feasibility and acceptability of a remote-delivered, single session of IR and a nutrition education control group in a community sample of adults with NEREAs.</p><p><strong>Methods: </strong>In this parallel two-arm pilot trial, participants completed an in-person baseline visit, one remote-delivered, single-session intervention (IR or attention-matched nutrition education control), and in-person 1- and 3-month follow-up visits between February 2023 and April 2024 in Oregon, USA. Markers of feasibility included recruitment, visit and survey completion rates, and intervention fidelity; acceptability was evaluated using participant feedback and instances of adverse events.</p><p><strong>Results: </strong>One hundred one adults completed a phone screen; 96% reported at least one NEREA. Most of these adults were ineligible because they met psychiatric disorder criteria and/or were taking medication known to influence mood and/or appetite. Thirty-two participants completed a baseline study visit; 89% of these participants (N = 27; mean age [SD] = 32.52 [15.78], range = 18-73; 56% cisgender women; 74.1% non-Hispanic White, 14.8% Asian, 11.1% Hispanic/Latine, 7.4% Black, and 3.7% multiracial) were randomly assigned (using a random number generator) to and completed an intervention condition (13 IR, 14 control). Curriculum adherence, on average, was 94% for IR and 97% for control. One-month retention was 82%, and 3-month retention was 59%. Post-intervention ratings indicated good acceptability for both arms. No adverse events occurred.</p><p><strong>Conclusions: </strong>The delivered interventions are feasible and acceptable to a community sample of men and women; as such, a future definitive trial is recommended. Additional strategies for increasing retention are needed. Single-session interventions, like IR, have the potential for high impact and reach. They are inherently flexible and cost-effective interventions that can be delivered across systems of care, while remote delivery mitigates concerns with stigma and access.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov, NCT06610318 . Registered on 23 September 2024-retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"51"},"PeriodicalIF":1.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12016433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144021088","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A cash transfer plus gender transformative economic empowerment intervention seeking to improve the wellbeing of caregivers of children and adolescents living with HIV in South Africa: a feasibility study protocol for a pilot cluster randomized trial.","authors":"Darshini Govindasamy, Nwabisa Shai, Nelly Mwandacha, Stanley Carries, Nokwanda Sithole, Kalysha Closson, Arvin Bhana, Lovemore Sigwadhi, Laura Washington, Andrew Gibbs, Angela Kaida","doi":"10.1186/s40814-025-01643-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01643-3","url":null,"abstract":"<p><strong>Background: </strong>In sub-Saharan Africa, HIV care is dependent on informal caregiving, typically by female family members. Informal caregiving has been associated with numerous negative effects on caregivers (i.e., depression, intimate partner violence (IPV), financial insecurity). These factors impact caregivers' ability to provide care and their own wellbeing. South Africa is home to approximately 17% of the world's children and adolescents living with HIV (CALHIV), making the development of initiatives that mitigate the negative effects of caregiving critical. This protocol details the design of a cluster randomized trial seeking to assess the feasibility, preliminary effectiveness, cost-effectiveness, and acceptability of a cash transfer plus gender transformative economic empowerment intervention for improving psychological wellbeing, depressive symptoms, gender equality, and economic outcomes of caregivers of CALHIV.</p><p><strong>Methods: </strong>Caregivers of CALHIV will be recruited from public sector HIV clinics within the eThekwini Municipality, KwaZulu-Natal, South Africa. Clusters will be randomly assigned to intervention or control groups. Participants in the intervention arm (n = 120) will receive cash transfers (ZAR350, USD $18.79) and enroll in a program (10 workshop sessions) over a 6-month period. Participants in the control arm (n = 120) will receive a monthly cash transfer (ZAR350, USD $18.79) for a 6-month period and a once-off standard mobile message, encouraging linkage to healthcare services. Participants will be interviewed at baseline and endline, at the 7-month mark, to collect socio-demographic, health and wellbeing status, IPV, costs and earnings, and food security data. The primary outcomes include consent rate, overall retention rate, workshops retention rate, cash transfer protocol adherence, staff perceptions on implementation, psychological wellbeing, depressive symptoms, and IPV. A qualitative study and economic evaluation will be conducted alongside the main trial to probe participant perceptions of the intervention and assess cost and cost-effectiveness.</p><p><strong>Discussion: </strong>This trial has the potential to inform a larger confirmatory trial which will be valuable for informing post-pandemic recovery efforts for caregivers of CALHIV and others disproportionally burdened by compounding health and social crises.</p><p><strong>Trial registration: </strong>PACTR202311618532061. Registry name: Pan African Clinical Trial Registry (PACTR), retrospectively registered on November 21, 2023; The first participant was enrolled on August 24, 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"52"},"PeriodicalIF":1.5,"publicationDate":"2025-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12020082/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025136","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Recruitment rates, retention rates, and follow-up completion in a Brief Intervention and Contact trial for suicidal behavior: a feasibility study.","authors":"Divya Soni, Balpreet Panesar, Alexander Dufort, Lucy Guan, Jennifer Lee, Dana Waldern, Stephanie Hathaway, Nitika Sanger, Sid Stacey, Luciano Minuzzi, Lehana Thabane, Zainab Samaan","doi":"10.1186/s40814-025-01635-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01635-3","url":null,"abstract":"<p><strong>Background: </strong>Suicide is a serious public health concern for which there are limited evidence-based interventions being employed. This feasibility study administered a Brief Intervention and Contact (BIC) trial adopted from the WHO Multisite Intervention Study on Suicidal Behaviors (SUPRE-MISS) and followed participants after they had been discharged from the inpatient hospital setting.</p><p><strong>Aims: </strong>To assess the recruitment and retention rates, follow-up visit completion, barriers to recruitment and retention, resources needed of employing this study, and data completion.</p><p><strong>Methods: </strong>Eligible participants were recruited from psychiatric inpatient settings, in Hamilton, Ontario. Adults with suicidal behavior were randomly allocated to BIC (intervention) plus treatment as usual (TAU) or treatment as usual (control) and were followed for 6 months. The intervention arm completed 9 follow-up points during the 6-month follow-up period post-discharge. Calculation of recruitment and retention rates and associated statistical analyses were completed using SPSS version 25.</p><p><strong>Results: </strong>A total of 154 participants were approached during the 8-month recruitment period, 60 participants were enrolled resulting in a recruitment rate of 7.625 participants per month. A total of 61 participants were recruited, with 1 duplicate. The retention rate was 47.5% for the recruited participants at the end of the study.</p><p><strong>Conclusions: </strong>Few suicide-based follow up interventions assess the feasibility of conducting the study. Retention was low for this study; however, participants outlined reasons for withdrawal that are consistent with other research areas related to mental health. Findings from this study will help inform suicide research on the barriers and challenges to participant recruitment and retention.</p><p><strong>Trial registration: </strong>NCT03825354, Registered January 30 th, 2019, ClinicalTrial.gov; https://clinicaltrials.gov/study/NCT03825354?cond=suicide&term=brief%20intervention%20and%20contact&rank=6.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"50"},"PeriodicalIF":1.5,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12004632/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143975008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"MIKROBE: a feasibility study for a randomised controlled trial of one-stage or two-stage surgery for prosthetic knee infection.","authors":"Rohini Terry, Sarah Dean, Patrick Hourigan, Hugh Ben Waterson, Vikki Wylde, Natalie Carpenter, Bethany Whale, Roy J Powell, Polly Tarrant, Antonieta Medina-Lara, Abtin Alvand, Andrew D Toms","doi":"10.1186/s40814-025-01634-4","DOIUrl":"https://doi.org/10.1186/s40814-025-01634-4","url":null,"abstract":"<p><strong>Background: </strong>Total knee replacement surgery is common, with over 107,000 operations performed in the UK in 2019. After surgery, about 1% of patients develop a deep infection, known as a prosthetic joint infection. Two types of operations, one- or two-stage revision surgery, are routinely performed to treat the infection. Re-infection rates are similar, but there is uncertainty regarding longer-term outcomes for patients. The aim of this study was to establish the feasibility of conducting a future randomised controlled trial that will compare clinical and cost-effectiveness of one-stage versus two-stage revision knee surgery for prosthetic joint infection.</p><p><strong>Methods: </strong>Following eligibility screening, consenting patients took part in an audio-recorded consultation with their surgeon and were then randomised on a 1:1 allocation to one-stage or two-stage revision surgery. Patient-reported outcome measures were administered at baseline and 3 and 6 months postoperatively. Embedded qualitative work with patient participants and nonparticipants and with surgeons to understand the acceptability of trial processes and involvement was undertaken. Patient and public involvement and engagement activities were conducted throughout the study.</p><p><strong>Results: </strong>Of 136 patients screened, only 3 were randomised and had surgery as part of the study. Qualitative data were collected from the three participants, as well as from two eligible patients who declined participation and two who withdrew from participation after the initial patient-surgeon consultation. Five surgeons took part in qualitative interviews prior to study end.</p><p><strong>Conclusion: </strong>This study indicated that a larger randomised controlled trial evaluating one-stage versus two-stage revision knee surgery for prosthetic joint infection is not feasible with the current straightforward randomised controlled trial design. Future research needs to consider the most appropriate study design and methodology to address this important research question.</p><p><strong>Trial registration: </strong>No.: NCT04458961.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"49"},"PeriodicalIF":1.5,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12001597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039953","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digital Assessment of Wellbeing in New Parents (DAWN-P): protocol of a randomised feasibility trial comparing digital screening for maternal postnatal depression with usual care screening.","authors":"Emily Eisner, Ria Agass, Elizabeth Camacho, Adedamola Falana, Mark Hann, Anulika Ifezue, Henna Lemetyinen, Holly Myers, Charlotte Stockton-Powdrell, Clare Tower, Kylie Watson, Pauline Whelan, Anja Wittkowski, Shôn Lewis","doi":"10.1186/s40814-025-01631-7","DOIUrl":"https://doi.org/10.1186/s40814-025-01631-7","url":null,"abstract":"<p><strong>Background: </strong>Meta-analyses indicate that 17% of mothers experience postnatal depression (PND) in the year following childbirth, with suicide the leading cause of direct maternal death between 6 weeks and 12 months postpartum. The consequences and costs of PND are particularly high due to impacts on infants as well as parents. If detected, PND usually responds well to psychological treatment and/or medication but national reports indicate > 50% of cases are undetected. To improve detection, we developed a digital screening system (CareLoop PND) whereby mothers use an app to monitor their mood daily using a validated measure (Edinburgh Postnatal Depression Scale; EPDS), with real-time responses uploaded to a secure server. In this paper, we describe the protocol of a study to determine feasibility of delivering a full-scale RCT comparing digital screening with standard NHS practice.</p><p><strong>Methods: </strong>In this single-blind randomised feasibility trial, participants (n = 80) will be recruited during late pregnancy from two NHS maternity services and randomised (1:1) to receive CareLoop PND alongside their usual NHS care, or usual care alone. Those in the experimental arm will use the CareLoop PND app daily from ≥ 36 weeks' pregnancy until 8 weeks postpartum. During this period, participants scoring above EPDS screening thresholds (via the app or standard care) will be assessed to confirm diagnosis. True positive PND cases identified by digital screening will be referred to services for support. A blinded researcher will conduct follow-up assessments using clinical and health economic measures at 8 weeks and 6 months postpartum. At 8 weeks postpartum, experimental arm participants will also provide qualitative and quantitative feedback exploring app usability, acceptability, and implementation. Feasibility of delivering a full-scale RCT will be evaluated using a priori criteria relating to app engagement, study retention and completion of candidate primary outcome measures.</p><p><strong>Conclusions: </strong>Digital screening could increase appropriate referral to perinatal mental health care. However, prior to roll out in NHS services, evidence of efficacy and cost-effectiveness is needed. The current study protocol will determine whether a full-scale RCT examining efficacy and cost-effectiveness is feasible and will inform the design of such a trial.</p><p><strong>Trial registration: </strong>Prospective ISRCTN registration (03/07/23): ISRCTN10781027; https://www.isrctn.com/ISRCTN10781027 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"47"},"PeriodicalIF":1.5,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11992709/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049460","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: A self-management intervention for newly diagnosed with inflammatory arthritis: a randomized controlled feasibility and fidelity study.","authors":"Luise Holberg Lindgren, Tanja Thomsen, Merete Lund Hetland, Mette Aadahl, Sara Danshøj Kristensen, Annette de Thurah, Bente Appel Esbensen","doi":"10.1186/s40814-025-01633-5","DOIUrl":"https://doi.org/10.1186/s40814-025-01633-5","url":null,"abstract":"","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"48"},"PeriodicalIF":1.5,"publicationDate":"2025-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11992727/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144049439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of sedative drugs in specialist palliative care (iSedPall): a multi-modal intervention pilot study protocol.","authors":"Christoph Ostgathe, Claudia Bausewein, Eva Schildmann, Jeremias Bazata, Maria Heckel, Saskia Kauzner, Carsten Klein, Sabine H Krauss, Alexander Kremling, Manuela Schneider, Andreas Seifert, Kerstin Ziegler, Christian Jäger, Jan Schildmann","doi":"10.1186/s40814-025-01627-3","DOIUrl":"https://doi.org/10.1186/s40814-025-01627-3","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;The use of sedative drugs in specialist palliative care is common but presents challenges due to specific medical, ethical, and legal considerations. There is little to no assistance for administering adequate sedative drug doses, ensuring accurate documentation before and during sedation, or managing ethically and legally challenging situations. In 2021, the SedPall study group published recommendations on the use of sedative drugs in palliative care. The German Association for Palliative Medicine endorsed the dissemination of the recommendations nationwide. However, disseminating recommendations alone does not necessarily lead to changes in clinical practice. In the project \"Development and piloting of a multi-modal intervention for the use of sedative drugs in specialist palliative care (iSedPall)\", we will develop a multi-modal intervention that implements these national recommendations into practical tools for healthcare professionals in specialist inpatient and home care settings. In the pilot study described below, we aim to test the feasibility of the multi-modal intervention, its appropriateness, and acceptability as primary feasibility outcomes of the multi-modal intervention. Additionally, we aim to assess the feasibility of measuring healthcare professionals´ confidence in using sedative drugs as an outcome indicator for a possible subsequent study.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods and analysis: &lt;/strong&gt;We will use a mixed-methods approach to develop and pilot a multi-modal intervention. The primary feasibility outcomes and formative evaluation of the implementation process will be explored using quantitative (retrospective cohort study, survey) and qualitative elements (focus groups, interviews). Additionally, we will pilot the measurement of healthcare professionals´ confidence in using sedative drugs as an outcome indicator through a pre-post survey. Four specialist palliative care services will pilot the complex intervention for nine months. Due to the complexity of the intervention, we will follow the principles of the MRC framework for complex interventions and will apply a Theory of Change approach. The intervention will include different elements to be used throughout the patients' treatment in inpatient and home specialist palliative care considering medical, ethical, and legal aspects for the use of sedative drugs and intentional sedation. The evaluation of the overall feasibility and the decision about proceeding to an implementation study will be based on the integration of quantitative and qualitative data, according to our mixed-methods approach.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This project is the first attempt to translate national recommendations on best practices for sedative drug use into a multi-modal intervention and tests its feasibility. The study group identified potential risks and challenges related to the intervention´s feasibility, acceptability, and appropriateness in advance. To mi","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"45"},"PeriodicalIF":1.5,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11984285/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mamas in Harmony: protocol for a pilot RCT and process evaluation of a music and social support intervention establishing the feasibility of reducing anxiety and stress in postnatal mothers.","authors":"Corinna A Colella, Jenny McNeill, Una McCann, Fiona A Lynn","doi":"10.1186/s40814-025-01629-1","DOIUrl":"https://doi.org/10.1186/s40814-025-01629-1","url":null,"abstract":"<p><strong>Background: </strong>Postnatal mothers can experience anxiety, stress and difficulty with mother-infant attachment with potential to lead to an anxiety disorder/depression. There has been an increase in interest in non-pharmacological interventions involving music, with limited evidence assessing effectiveness in this population within randomised controlled trials (RCTs). Mamas in Harmony is a novel music/social support intervention. The objective is to assess the feasibility/acceptability of conducting a full RCT to test the effect and cost-effectiveness of Mamas in Harmony compared with usual care.</p><p><strong>Methods: </strong>The pilot RCT aims to recruit 60 mother-infant dyads through social media, community organisations and stakeholder networks, randomly allocated on a 2:1 ratio to the intervention and control group. The intervention group will receive eight 1 h weekly Mamas in Harmony sessions plus usual care, and the control group will receive usual care only. Feasibility measures include recruitment, retention and attendance at intervention sessions. The process evaluation aims to establish acceptability of the intervention involving survey evaluation and semi-structured interviews. A priori guidelines have been agreed to establish criteria for progression to a definitive RCT.</p><p><strong>Discussion: </strong>The current evidence supports the use of music in reducing anxiety and stress with the recommendation for inclusion of social support. This study has potential to provide robust evidence of the feasibility and acceptability of a music and social support mother-infant group intervention in preparation for a future definitive trial, should progression criteria be met.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov ID: NCT05930990 , registered retrospectively on 5 July 2023. Recruitment commenced on 16 March 2023.</p><p><strong>Protocol version: </strong>30 October 2023 Vn 1.0.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"44"},"PeriodicalIF":1.5,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11984032/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144050031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Development and testing of mobile phone text messages for improving maternal and newborn care practice in Jimma Zone, Ethiopia: a user-centered design approach.","authors":"Hordofa Gutema Abdissa, Gebeyehu Bulcha Duguma, Josef Noll, Demisew Amenu Sori, Zewdie Birhanu Koricha","doi":"10.1186/s40814-025-01632-6","DOIUrl":"https://doi.org/10.1186/s40814-025-01632-6","url":null,"abstract":"<p><strong>Background: </strong>Mobile phone-based messaging for maternal education has indicated promising outcomes in promoting maternal and newborn care practices. However, most mobile phone-based messaging interventions are not tested before their implementation, and the evidence on the message content development process and methods is limited and underreported. The aim of this study was to develop and test text messages for interventions designed to improve maternal services utilization and newborn care practices.</p><p><strong>Methods: </strong>The development process has 4 phases: engaging pregnant mothers and experts in selected districts of the Jimma Zone, Ethiopia. During phase 1, the draft messages were developed based on the message framing concept, and the number of messages was reduced after review. In phase 2, 12 mothers participated in card sorting and the messages were refined. In phase 3, 8 experts evaluated the messages using 10 items with a 5-point Likert scale. In phase 4, a pilot study (n = 30) was conducted to evaluate the messages and their delivery when they were sent to individuals' mobile telephones. In this phase, a system usability scale was also used to assess the usability of the planned intervention.</p><p><strong>Results: </strong>An initial bank of 120 messages was developed, 42 of which were discarded during the development process. Of these, 32 were discarded by the research team at phase 1, and 10 were discarded during the card sorting at phase 2. Based on the experts' evaluations, 14 messages were reworded and refined in phase 3. During the pilot testing phase, the majority (80%) of the participants mentioned that the time they had been receiving the message was early, and 66.7% of the participants preferred the time to receive text messages about health. The mean SUS score was 72.26, which is acceptable for the usability of the mobile phone-based messaging intervention.</p><p><strong>Conclusion: </strong>A final bank of 78 (39 for each framing type) messages was obtained after refinement according to feedback from participants. The SUS showed an acceptable score for the planned intervention. This message development process confirms that the messages are acceptable, and important for improving maternal and newborn health care practices.</p><p><strong>Trial registration: </strong>PACTR202201753436676.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"46"},"PeriodicalIF":1.5,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144037047","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determining the feasibility and acceptability of a randomized telehealth pilot study for veterans with chronic multisymptom illness.","authors":"Charity B Breneman, Kamila Pollin, Timothy Chun, Lucas Crock, Walter Jachimowicz, Rebecca A McCullers, Ryan C Brewster, Adil Alaoui, Anas Belouali, Michael J Roy, Matthew J Reinhard, Michelle E Costanzo","doi":"10.1186/s40814-025-01628-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01628-2","url":null,"abstract":"<p><strong>Background: </strong>The shift toward a patient-centered and whole health care model offers a promising approach for the management of symptoms among veterans with chronic multisymptom illness (CMI). A behavioral intervention aimed at reducing cognitive control dysregulation which is a component of impairments common among veterans with CMI may be helpful. Therefore, a pilot study was conducted to explore the feasibility, safety, and acceptability of a telehealth mental and physical (MAP) training intervention among veterans with CMI.</p><p><strong>Methods: </strong>Utilizing a two-arm randomized trial, participants were either randomized to 8 weeks of a directed MAP training protocol (dMAP) that received weekly guidance via text messaging or 8 weeks of self-guided MAP training (sgMAP) which did not receive guidance aside from the intervention goals. The MAP intervention was the same for both groups except for the delivery and consisted of two MAP training sessions and one telephone health coaching session per week. The primary aim of the study was to evaluate the feasibility (e.g., recruitment, retention, and adherence rates; amount of missing data), safety (e.g., adverse events), and acceptability (e.g., satisfaction) of a telehealth MAP intervention.</p><p><strong>Results: </strong>Out of 44 potentially eligible veterans, 26 were randomized to either the dMAP group (n = 13) or the sgMAP group (n = 13), resulting in a recruitment rate of 59% (26/44 patients). Two participants withdrew after randomization, resulting in 24 participants used for analyses. The retention rates at endpoint and 3-month follow-up were 79.2% (19/24; dMAP:sgMAP = 9:10) and 62.5% (15/24; dMAP:sgMAP = 7:8), respectively. Participants completed an average of 48.2% of the MAP sessions (7.7/16 sessions; dMAP:sgMAP = 7.9:7.5 sessions) and 82.8% of the health coaching sessions (6.6/8 sessions; dMAP:sgMAP = 7.2:6.2 sessions). Missing data was minimal, and no adverse events related to the study were reported. Acceptability was high as veterans were satisfied with the wearables and valued the health coaching support.</p><p><strong>Conclusions: </strong>This pilot study provides insights into the feasibility of a large-scale randomized control trial that promotes meditation and physical activity to augment cognitive control to facilitate self-regulation. Future efforts should expand recruitment strategies and add internal data quality monitoring.</p><p><strong>Trial registration: </strong>NCT04164667, retrospectively registered November 12, 2019, https://clinicaltrials.gov/study/NCT04164667.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"43"},"PeriodicalIF":1.5,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11983819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144011283","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}