Wei Liang , Ka Ming Chow , Xiaoying Ni , Yetunde Oluwafunmilayo Tola , Suzanne Hoi Shan Lo
{"title":"护士主导的糖尿病自我管理计划对接受胰岛素注射治疗的2型糖尿病患者的影响:一项带有定性过程评价的随机对照试验","authors":"Wei Liang , Ka Ming Chow , Xiaoying Ni , Yetunde Oluwafunmilayo Tola , Suzanne Hoi Shan Lo","doi":"10.1016/j.ijnurstu.2025.105200","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Many people with type 2 diabetes eventually require and benefit from insulin injection therapy, but only a minority of people receiving such therapy meet their glycaemic targets. Thus, effective diabetes self-management programmes are needed to support this cohort.</div></div><div><h3>Objective</h3><div>To examine the effects of a nurse-led diabetes self-management programme on self-efficacy, self-management behaviours, glycaemic control, and diabetes-related distress of Chinese people with type 2 diabetes receiving insulin injection therapy, and to collect their experiences and perceived benefits of and feedback on the programme.</div></div><div><h3>Design</h3><div>A prospective, two-arm, assessor-blinded, randomised controlled trial with repeated measures and qualitative process evaluation.</div></div><div><h3>Setting</h3><div>Participants were recruited from a public community health service centre.</div></div><div><h3>Participants</h3><div>One hundred and two participants (mean age: 64.03 years, standard deviation = 9.77 years) were recruited and then randomly assigned to the intervention group or the attention control group.</div></div><div><h3>Methods</h3><div>The intervention group (n = 51) received a 6-week nurse-led diabetes self-management programme. This intervention was underpinned by Bandura's theory of self-efficacy and consisted of one individual interview session, three group-based education sessions, and two telephone-based maintenance sessions. The attention control group (n = 51) received parallel 6-week attention control contact. Outcome variables were measured at baseline (T0), upon completion of the intervention (T1), and at 3 months post-intervention (T2).</div></div><div><h3>Results</h3><div>At T0, there were no significant between-group differences in characteristics, except for education level, and no significant between-group differences in any outcome variables. At T1, compared with the attention control group, the intervention group exhibited significantly enhanced self-efficacy (<span><math><mi>β</mi></math></span> = 17.341, <em>p</em> <span><math><mo><</mo></math></span> 0.001), improved self-management behaviours (<span><math><mi>β</mi></math></span> = 0.696, <em>p</em> <span><math><mo><</mo></math></span> 0.001), and reduced diabetes-related distress (<span><math><mi>β</mi></math></span> = <span><math><mo>−</mo></math></span>0.160, <em>p</em> = 0.015). However, at T2, compared with the attention control group, the intervention group did not demonstrate significant improvement in any outcome variables (all <em>p</em> <span><math><mo>></mo></math></span> 0.05). No adverse effects were reported by the participants. Qualitative interviews of 21 participants of the intervention group generated responses that could be categorised under four themes, namely perspectives on receiving the intervention, benefits of the intervention, barriers to behavioural change, and areas for improvement.</div></div><div><h3>Conclusions</h3><div>The nurse-led programme was effective in enhancing self-efficacy, improving self-management behaviours, and alleviating diabetes-related distress in Chinese people with type 2 diabetes receiving insulin injection therapy. Based on the findings of the qualitative evaluation, suggestions are made regarding modifications and large-scale implementation that can be explored in future research.</div></div><div><h3>Trial registration</h3><div>Chinese Clinical Trial Registry (ChiCTR); ChiCTR2100046342 (<span><span>https://www.chictr.org.cn/showproj.html?proj=126516</span><svg><path></path></svg></span>).</div></div><div><h3>Registration data</h3><div>May 14, 2021.</div></div>","PeriodicalId":50299,"journal":{"name":"International Journal of Nursing Studies","volume":"171 ","pages":"Article 105200"},"PeriodicalIF":7.1000,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Effects of a nurse-led diabetes self-management programme for people with type 2 diabetes receiving insulin injection therapy: A randomised controlled trial with qualitative process evaluation\",\"authors\":\"Wei Liang , Ka Ming Chow , Xiaoying Ni , Yetunde Oluwafunmilayo Tola , Suzanne Hoi Shan Lo\",\"doi\":\"10.1016/j.ijnurstu.2025.105200\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Many people with type 2 diabetes eventually require and benefit from insulin injection therapy, but only a minority of people receiving such therapy meet their glycaemic targets. Thus, effective diabetes self-management programmes are needed to support this cohort.</div></div><div><h3>Objective</h3><div>To examine the effects of a nurse-led diabetes self-management programme on self-efficacy, self-management behaviours, glycaemic control, and diabetes-related distress of Chinese people with type 2 diabetes receiving insulin injection therapy, and to collect their experiences and perceived benefits of and feedback on the programme.</div></div><div><h3>Design</h3><div>A prospective, two-arm, assessor-blinded, randomised controlled trial with repeated measures and qualitative process evaluation.</div></div><div><h3>Setting</h3><div>Participants were recruited from a public community health service centre.</div></div><div><h3>Participants</h3><div>One hundred and two participants (mean age: 64.03 years, standard deviation = 9.77 years) were recruited and then randomly assigned to the intervention group or the attention control group.</div></div><div><h3>Methods</h3><div>The intervention group (n = 51) received a 6-week nurse-led diabetes self-management programme. This intervention was underpinned by Bandura's theory of self-efficacy and consisted of one individual interview session, three group-based education sessions, and two telephone-based maintenance sessions. The attention control group (n = 51) received parallel 6-week attention control contact. Outcome variables were measured at baseline (T0), upon completion of the intervention (T1), and at 3 months post-intervention (T2).</div></div><div><h3>Results</h3><div>At T0, there were no significant between-group differences in characteristics, except for education level, and no significant between-group differences in any outcome variables. At T1, compared with the attention control group, the intervention group exhibited significantly enhanced self-efficacy (<span><math><mi>β</mi></math></span> = 17.341, <em>p</em> <span><math><mo><</mo></math></span> 0.001), improved self-management behaviours (<span><math><mi>β</mi></math></span> = 0.696, <em>p</em> <span><math><mo><</mo></math></span> 0.001), and reduced diabetes-related distress (<span><math><mi>β</mi></math></span> = <span><math><mo>−</mo></math></span>0.160, <em>p</em> = 0.015). However, at T2, compared with the attention control group, the intervention group did not demonstrate significant improvement in any outcome variables (all <em>p</em> <span><math><mo>></mo></math></span> 0.05). No adverse effects were reported by the participants. Qualitative interviews of 21 participants of the intervention group generated responses that could be categorised under four themes, namely perspectives on receiving the intervention, benefits of the intervention, barriers to behavioural change, and areas for improvement.</div></div><div><h3>Conclusions</h3><div>The nurse-led programme was effective in enhancing self-efficacy, improving self-management behaviours, and alleviating diabetes-related distress in Chinese people with type 2 diabetes receiving insulin injection therapy. Based on the findings of the qualitative evaluation, suggestions are made regarding modifications and large-scale implementation that can be explored in future research.</div></div><div><h3>Trial registration</h3><div>Chinese Clinical Trial Registry (ChiCTR); ChiCTR2100046342 (<span><span>https://www.chictr.org.cn/showproj.html?proj=126516</span><svg><path></path></svg></span>).</div></div><div><h3>Registration data</h3><div>May 14, 2021.</div></div>\",\"PeriodicalId\":50299,\"journal\":{\"name\":\"International Journal of Nursing Studies\",\"volume\":\"171 \",\"pages\":\"Article 105200\"},\"PeriodicalIF\":7.1000,\"publicationDate\":\"2025-08-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Nursing Studies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S002074892500210X\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"NURSING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Nursing Studies","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S002074892500210X","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"NURSING","Score":null,"Total":0}
引用次数: 0
摘要
许多2型糖尿病患者最终需要并受益于胰岛素注射治疗,但只有少数接受这种治疗的人达到了他们的血糖目标。因此,需要有效的糖尿病自我管理规划来支持这一队列。目的探讨护士主导的糖尿病自我管理项目对接受胰岛素注射治疗的中国2型糖尿病患者的自我效能感、自我管理行为、血糖控制和糖尿病相关困扰的影响,并收集他们的经验、感知收益和反馈。设计一项前瞻性、双臂、评估者盲法、随机对照试验,采用重复测量和定性过程评价。参与者是从公共社区卫生服务中心招募的。参与者共招募102名参与者(平均年龄64.03岁,标准差9.77岁),随机分为干预组和注意对照组。方法干预组51例患者接受为期6周的护士糖尿病自我管理计划。这种干预以班杜拉的自我效能理论为基础,包括一次个人访谈、三次小组教育和两次电话维护。注意控制组(n = 51)接受平行的6周注意控制接触。在基线(T0)、干预完成(T1)和干预后3个月(T2)测量结果变量。结果T0组间除受教育程度外,其他特征均无显著性差异,其他结局变量均无显著性差异。在T1时,干预组与注意对照组相比,自我效能感显著增强(β = 17.341, p < 0.001),自我管理行为显著改善(β = 0.696, p < 0.001),糖尿病相关困扰显著减少(β = - 0.160, p = 0.015)。然而,在T2时,与注意对照组相比,干预组在任何结果变量上均无显著改善(均p >; 0.05)。参与者没有报告不良反应。对干预组的21名参与者进行了定性访谈,得出的回答可以分为四个主题,即接受干预的观点、干预的好处、行为改变的障碍和需要改进的领域。结论在接受胰岛素注射治疗的中国2型糖尿病患者中,护士主导的项目能有效提高自我效能感,改善自我管理行为,减轻糖尿病相关困扰。根据定性评估的结果,提出了修改和大规模实施的建议,可以在未来的研究中探索。中国临床试验注册中心(ChiCTR);ChiCTR2100046342 (https://www.chictr.org.cn/showproj.html?proj=126516).Registration data2021年5月14日。
Effects of a nurse-led diabetes self-management programme for people with type 2 diabetes receiving insulin injection therapy: A randomised controlled trial with qualitative process evaluation
Background
Many people with type 2 diabetes eventually require and benefit from insulin injection therapy, but only a minority of people receiving such therapy meet their glycaemic targets. Thus, effective diabetes self-management programmes are needed to support this cohort.
Objective
To examine the effects of a nurse-led diabetes self-management programme on self-efficacy, self-management behaviours, glycaemic control, and diabetes-related distress of Chinese people with type 2 diabetes receiving insulin injection therapy, and to collect their experiences and perceived benefits of and feedback on the programme.
Design
A prospective, two-arm, assessor-blinded, randomised controlled trial with repeated measures and qualitative process evaluation.
Setting
Participants were recruited from a public community health service centre.
Participants
One hundred and two participants (mean age: 64.03 years, standard deviation = 9.77 years) were recruited and then randomly assigned to the intervention group or the attention control group.
Methods
The intervention group (n = 51) received a 6-week nurse-led diabetes self-management programme. This intervention was underpinned by Bandura's theory of self-efficacy and consisted of one individual interview session, three group-based education sessions, and two telephone-based maintenance sessions. The attention control group (n = 51) received parallel 6-week attention control contact. Outcome variables were measured at baseline (T0), upon completion of the intervention (T1), and at 3 months post-intervention (T2).
Results
At T0, there were no significant between-group differences in characteristics, except for education level, and no significant between-group differences in any outcome variables. At T1, compared with the attention control group, the intervention group exhibited significantly enhanced self-efficacy ( = 17.341, p 0.001), improved self-management behaviours ( = 0.696, p 0.001), and reduced diabetes-related distress ( = 0.160, p = 0.015). However, at T2, compared with the attention control group, the intervention group did not demonstrate significant improvement in any outcome variables (all p 0.05). No adverse effects were reported by the participants. Qualitative interviews of 21 participants of the intervention group generated responses that could be categorised under four themes, namely perspectives on receiving the intervention, benefits of the intervention, barriers to behavioural change, and areas for improvement.
Conclusions
The nurse-led programme was effective in enhancing self-efficacy, improving self-management behaviours, and alleviating diabetes-related distress in Chinese people with type 2 diabetes receiving insulin injection therapy. Based on the findings of the qualitative evaluation, suggestions are made regarding modifications and large-scale implementation that can be explored in future research.
Trial registration
Chinese Clinical Trial Registry (ChiCTR); ChiCTR2100046342 (https://www.chictr.org.cn/showproj.html?proj=126516).
期刊介绍:
The International Journal of Nursing Studies (IJNS) is a highly respected journal that has been publishing original peer-reviewed articles since 1963. It provides a forum for original research and scholarship about health care delivery, organisation, management, workforce, policy, and research methods relevant to nursing, midwifery, and other health related professions. The journal aims to support evidence informed policy and practice by publishing research, systematic and other scholarly reviews, critical discussion, and commentary of the highest standard. The IJNS is indexed in major databases including PubMed, Medline, Thomson Reuters - Science Citation Index, Scopus, Thomson Reuters - Social Science Citation Index, CINAHL, and the BNI (British Nursing Index).