Implementation of personalized self-management support using the self-management screening questionnaire SeMaS; a study protocol for a cluster randomized trial
Open accessAbstract
BACKGROUND: The number of patients with one or more chronic diseases is rising. In several standards of care there is a focus on enhancing self-management. We applied the concept of personalization on self-management support and developed a self-management screening questionnaire (SeMaS). The main research objective is to assess the effectiveness of the SeMaS questionnaire and subsequent personalized self-management on patients' self-management behaviors. METHODS/DESIGN: A cluster randomized controlled trial will be set up in 15 general practices in the Netherlands. The practices are all group practices, and member of one care group. The practices will be assigned to the control or intervention arms by stratified randomization. The strata are determined by the participation of the practice nurses in a course for behavioral change, and the nurse's workload. Patients can be included if they are over 18 years of age, have at least one chronic condition and have a checkup appointment with the practice nurse in the inclusion period. The intervention consists of screening patients with the SeMaS questionnaire, producing a graphic profile with the abilities or barriers for self-management. Patients will receive tailored feedback. Practice nurses are trained in using the profile to enhance self-management of the patient and provide personalized self-management support. The use of individual care plans and self-management interventions is stimulated. In the control arm patients will receive care as usual. Patients of both trial arms will be asked to fill in the SeMaS questionnaire and additional questionnaires at inclusion and after 6 months. The primary outcome is the difference in the level of patient activation (PAM-13) between baseline and 6 months. Secondary outcomes include patient measures for lifestyle factors (exercise, diet, smoking), and process measures from medical record data analysis. DISCUSSION: This manuscript presents the protocol for a cluster randomized clinical trial of personalized self-management support using the SeMaS questionnaire in chronically ill patients in primary care. By carrying out this study, scientific evidence is built for the effectiveness of personalized self-management support. TRIAL REGISTRATION: The Netherlands National Trial Register: NTR3960.
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Eikelenboom et al. reported no significant difference in PAM-13 scores between control and intervention arms at six-month follow-up.
“Eikelenboom et al. reported no significant difference in PAM-13 scores (measure of patient activation [132]) between control and intervention arms at six-month follow-up”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [105]
The Methods/Design—Outcomes section specifies a six-month comparison of PAM-13 scores between the intervention and control arms. But this paper is a study protocol: the Analysis section describes a planned test, not a completed one. It does not report that the difference was nonsignificant. (LLM, conf=0.86)
Experimental — accuracy not yet measuredFive studies reported on level of physical activity.
“Five studies reported on level of physical activity”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [105]
The Methods/Design > Outcomes passage says the trial planned to measure physical activity with the RAPA questionnaire. This study protocol does not report measured physical-activity levels, so it supports identifying physical activity as a planned outcome, but not counting the paper as a study that reported levels. (LLM, conf=0.82)
Experimental — accuracy not yet measuredNo significant between-group differences were reported for physical activity in 4 RCTs.
“No significant between group differences were reported for physical activity in 4 RCTs”
From Helping patients help themselves: A systematic review of self-management support strategies in primary health care practice (2019) · cites this paper as [105]
The Methods/Design > Outcomes passage describes a planned comparison of physical activity between intervention and control groups, not trial results. A search for significant between-group differences and four RCTs found no passage reporting the claimed finding. Page numbers are unavailable in our copy. (LLM, conf=0.77)
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 [105]
The Methods/Design sections describe a planned cluster-randomized trial and expected outcomes, not results from seven RCTs. Searches for seven RCTs and non-significant improvements in self-efficacy found no passage reporting the claimed finding. (LLM, conf=0.77)
Experimental — accuracy not yet measured
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- Authors
- Eikelenboom, N., van Lieshout, J., Wensing, M., Smeele, I., & Jacobs, A. E.
- Affiliations
- Radboud University Medical Center (NL)
- DOH Zorggroep (NL)
- Corresponding author
- Eikelenboom, Nathalie
- Venue
- Trials
- Published
- 2013
- Volume
- 14
- Issue
- 1
- Pages
- 336
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC3874773
- OpenAlex
- W2114818586
- Cited by
- 26
- References
- 40
- Citations by year
- 2024: 7 · 2023: 4 · 2022: 2 · 2021: 2 · 2020: 1 · 2019: 3 · 2017: 1 · 2016: 2 · 2015: 3 · 2014: 1
- FWCI
- 1.46
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Epidemiology › Chronic Disease Management Strategies
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Education
- Health Sciences › Health Professions › Pharmacy › Nursing care and research
- Keywords
- sema, chronic disease, patient activation, primary care, practice nurses, personalized feedback, self-management behavior, lifestyle factors, physical activity, diet, smoking, care planning
- MeSH terms
- Chronic Disease, Clinical Protocols, Humans, Health Knowledge, Attitudes, Practice, Netherlands, Predictive Value of Tests, Primary Health Care, Surveys and Questionnaires, Research Design, Risk Factors, Self Care, Time Factors, Health Behavior, Comorbidity, Risk Reduction Behavior, Precision Medicine
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