Lessons learnt from a cluster-randomised trial evaluating the effectiveness of Self-Management Support (SMS) delivered by practice nurses in routine diabetes care
Open accessAbstract
Objective: To evaluate the effectiveness of biopsychosocial Self-Management Support (SMS) delivered by practice nurses in routine diabetes care. Design: A pragmatic cluster-randomised controlled trial within a hybrid effectiveness-implementation study design. Practice nurses were cluster-randomised. Setting: A regional care group in the Netherlands consisting of 77 family practices. The study involved practice nurses (n=40) providing care to approximately 4000 patients with diabetes. Participants: Patients with type 2 diabetes (n=264) selected by a self-administered questionnaire aimed at measuring emotional distress and diabetes-related reduced daily functioning. Intervention: Practice nurses in the intervention arm (n=19) were trained to integrate SMS into their routine consultations. SMS included detection of patients with emotional distress and reduced daily functioning, and supporting them when needed through problem solving and reattribution techniques. Practice nurses in the control arm (n=21) provided usual care. Main outcome measures: The primary outcome measure was a dichotomised score on a Visual Analogue Scale that measured the perceived effect of diabetes on daily functioning. Secondary measures included patients’ diabetes-related distress, quality of life, autonomy and participation, self-efficacy, self-management and glycaemic control. Outcomes were measured at baseline and at 4-month and 12-month follow-ups. Results: Only 16 of the 117 patients in the intervention arm (14%) who were found eligible by the posted research-driven screening questionnaire were detected by their practice nurses. Extra consultations for the self-management support were delivered to only 11 study participants. In the control arm, 147 patients received usual care. Multilevel analyses showed no significant differences in outcomes between the intervention and control arms. Conclusions: SMS in its present form was not effective. The research-driven screening to select trial participants appeared to be inconsistent with nurse-led detection in routine practice. Adequate follow-up moments need to be built in to overcome barriers resulting from tension between the implementation and effectiveness parts of hybrid studies. Trial registration number: Current Controlled Trials NTR2764.
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Physical, mental or social functioning were measured in 25 RCTs.
“Physical, mental or social functioning were measured in 25 RCTs”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [57]
The Methods > Outcomes and Results > Baseline characteristics passages show that this trial measured physical and mental quality-of-life components and social participation. They do not support the claim that these outcomes were measured in 25 RCTs; the cited paper reports a single cluster-randomised trial. (LLM, conf=0.83)
Experimental — accuracy not yet measuredSeven RCTs reported non-significant improvements in self-efficacy.
“Seven RCTs reported non-significant improvements in self-efficacy”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [57]
The Results (Secondary outcomes, Table 4; page unavailable) show a small, non-significant positive self-efficacy effect at four months (+0.15, p=0.81). At 12 months the effect was negative (−0.69, p=0.27). This paper reports one cluster-randomised trial, so it cannot establish that seven RCTs reported improvements. (LLM, conf=0.86)
Experimental — accuracy not yet measuredTwenty-four RCTs examined the impact of interventions on health-related quality of life (HRQOL).
“Twenty-four RCTs examined the impact of interventions on HRQOL”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [57]
The Results sections report outcomes from this paper’s cluster-randomised diabetes-care trial, including quality-of-life measures, but do not report a set of 24 RCTs. Searches for “Twenty-four RCTs” and “24 randomized controlled trials” found no passage supporting that count. (LLM, conf=0.77)
Experimental — accuracy not yet measuredChanges in perceived self-efficacy were reported in 14 studies.
“Changes in perceived self-efficacy were reported in 14 studies”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [57]
The Methods > Outcomes section describes a self-efficacy measure, and Results > Secondary outcomes reports self-efficacy results from this trial. Neither section reports a count of studies; searches for the quoted sentence and for “14 studies” found no passage supporting that count. Page numbers were not available in our copy. (LLM, conf=0.76)
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- Authors
- van Dijk-de Vries, A., van Bokhoven, M. A., Winkens, B., Terluin, B., Knottnerus, J. A., van der Weijden, T., & van Eijk, J. T. M.
- Affiliations
- Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
- Department of Methodology and Statistics, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
- Amsterdam Public Health (NL)
- Maastricht University (NL)
- Department of Social Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, Maastricht, The Netherlands
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2015-06
- Volume
- 5
- Issue
- 6
- Pages
- e007014
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC4486946
- OpenAlex
- W2310238495
- Cited by
- 25
- References
- 40
- Citations by year
- 2026: 4 · 2025: 1 · 2024: 1 · 2023: 5 · 2021: 4 · 2020: 1 · 2019: 2 · 2018: 2 · 2017: 2 · 2016: 1 · 2015: 2
- FWCI
- 2.03
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by-nc
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Research Publications (Maastricht University) (submittedVersion, cc-by-nc)
- Pure Amsterdam UMC (submittedVersion, other-oa)
- Radboud Repository (Radboud University) (submittedVersion)
- Radboud Repository (Radboud University) (submittedVersion, other-oa)
- Research Publications (Maastricht University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Diabetes Fonds (2010.13.1366)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Medicine › Epidemiology › Chronic Disease Management Strategies
- Health Sciences › Health Professions › General Health Professions › Patient-Provider Communication in Healthcare
- Keywords
- self-management support, type 2 diabetes, practice nurses, nurse-led care, diabetes distress, emotional distress screening, daily functioning, glycemic control, self-efficacy, quality of life, implementation effectiveness, hybrid effectiveness-implementation study, primary care
- MeSH terms
- Activities of Daily Living, Aged, Diabetes Mellitus, Type 2, Female, Humans, Male, Middle Aged, Nurses, Primary Health Care, Self Care, Stress, Psychological, Cluster Analysis, Treatment Outcome
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