A randomised controlled trial to assess the feasibility and acceptability of remote psychosocial and exercise interventions for people with lupus: The ADAPT feasibility trial.
Melanie Sloan, Thomas A Pollak, David D'Cruz, Wendy Diment, Michael Bosley, Elliott Lever, Farhana Mann, Benjamin Sloan, James Brimicombe, Stephen Morris, Felix Naughton
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引用次数: 0
Abstract
Limited psychosocial support is available for people with lupus despite the highly reduced quality of life. This study assessed the acceptability, feasibility, and effectiveness estimations, of three (two psychosocial, one exercise) interventions. Lupus patients (N = 124) were randomised to a control arm or one of three interventions delivered remotely over 8-12 weeks: (1) listening support (The Wren project), (2) online Pilates classes, and (3) a text message and video support programme. Online follow up surveys post-intervention and six-months post-baseline included validated instruments for depression (PHQ-8), fatigue (FACIT-F), resilience (CD-RISC), acceptability measures and our co-designed "ADAPT" measure. A subsample of participants completed qualitative interviews. Hedge's g and linear regression were used to estimate effectiveness. All interventions were feasible in terms of recruitment, time, and costs, and met the pre-defined acceptability criteria of > 75% rating the intervention as acceptable/highly acceptable. Helpfulness ratings were highest for listening support with 89% rating it as often/always helpful (62% for Pilates and 52% for Text/videos). Proportions of participants reporting that the intervention had made them feel better mentally often/always was 71% for The Wren, 57% for Pilates and 48% for the text/video group. Qualitatively, the listening support participants valued the "safe space" to talk, and several of the exercise class participants reported improvements to physical and mental health. Although the text message and video programme was acceptable, feasible, and very low cost, 41% of participants would rather have received a different intervention. Suggested text/video adaptations included greater tailoring, particularly to stage of disease journey. Attendance was low for Pilates (only 55% attended > 50% of classes). Estimates of effectiveness favoured all interventions compared to control, although most improvements reduced with time. The interventions were feasible to deliver and acceptable to patients, with indications of potential effectiveness. Further studies are needed to determine effectiveness.Trial registration: ISRCTN72406488.
期刊介绍:
RHEUMATOLOGY INTERNATIONAL is an independent journal reflecting world-wide progress in the research, diagnosis and treatment of the various rheumatic diseases. It is designed to serve researchers and clinicians in the field of rheumatology.
RHEUMATOLOGY INTERNATIONAL will cover all modern trends in clinical research as well as in the management of rheumatic diseases. Special emphasis will be given to public health issues related to rheumatic diseases, applying rheumatology research to clinical practice, epidemiology of rheumatic diseases, diagnostic tests for rheumatic diseases, patient reported outcomes (PROs) in rheumatology and evidence on education of rheumatology. Contributions to these topics will appear in the form of original publications, short communications, editorials, and reviews. "Letters to the editor" will be welcome as an enhancement to discussion. Basic science research, including in vitro or animal studies, is discouraged to submit, as we will only review studies on humans with an epidemological or clinical perspective. Case reports without a proper review of the literatura (Case-based Reviews) will not be published. Every effort will be made to ensure speed of publication while maintaining a high standard of contents and production.
Manuscripts submitted for publication must contain a statement to the effect that all human studies have been reviewed by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in an appropriate version of the 1964 Declaration of Helsinki. It should also be stated clearly in the text that all persons gave their informed consent prior to their inclusion in the study. Details that might disclose the identity of the subjects under study should be omitted.