Trial reportContemporary clinical trials2022
Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model.
Trial report in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04334109 (Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparative Effectiveness of Family DSMES and Standard DSMES Among Diverse Populations
Who cites it
4 citing papers in PubMed, 7 citations in OpenAlex.
- Comparative effectiveness of telehealth-delivered family and standard models of diabetes self-management education and support for persons with type 2 diabetes mellitus.Diabetes research and clinical practice · 2026Trial
- Family model diabetes self-management education and support in faith-based organizations in the Republic of the Marshall Islands: A study protocol.Contemporary clinical trials · 2024Article
- Formative research to adapt the 'Diabetes Prevention Program- Power to Prevent' for implementation in Bamako, Mali.BMC health services research · 2024Article
- Rural Research Network to engage rural and minority community members in translational research.Journal of clinical and translational research · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundDiabetes self-management education and support (DSMES) is an effective approach for improving diabetes self-care behaviors to achieve improved glycemic management and other health outcomes. Engaging family members may improve outcomes, both for the person with diabetes (PWD) and for the family members. However, family models of DSMES have been inconsistently defined and delivered. We operationalize Family-DSMES to be generalizable and replicable, detail our protocol for a comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods implementation evaluation plan.
methodsWe will examine Family-DSMES relative to Standard-DSMES using a Hybrid Type 1 effectiveness-implementation design. Participants are ≥18 years old with type 2 diabetes mellitus and hemoglobin A1c ≥7.0%, recruited from rural and urban primary care clinics that are part of an academic medical center. Each participant invites a family member. Dyads are randomly assigned to Family- or Standard-DSMES, delivered in a small-group format via telehealth. Data are collected at baseline, immediately post-intervention, and 6-, 12-, and 18-months post-intervention. Outcomes include PWDs' hemoglobin A1c (primary), other biometric, behavioral, and psychosocial outcomes (secondary), and family members' diabetes-related distress, involvement in the PWD's diabetes management, self-efficacy for providing support, and biometric outcomes (exploratory). Our mixed-methods implementation evaluation will include process data collected during the trial and stakeholder interviews guided by the Consolidated Framework for Implementation Research.
conclusionResults will fill knowledge gaps about which type of DSMES may be most effective and guide Family-DSMES implementation efforts. REGISTRATION: The trial is pre-registered at clinicaltrials.gov (#NCT04334109).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.