Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams.
Chronic conditions
Diabetes
Feasibility trial
Health care volunteers
Hypertension
Primary care
Self-management
eHealth
Journal
Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536
Informations de publication
Date de publication:
2019
2019
Historique:
received:
09
05
2019
accepted:
21
09
2019
entrez:
2
11
2019
pubmed:
2
11
2019
medline:
2
11
2019
Statut:
epublish
Résumé
Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers ( Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.
Sections du résumé
BACKGROUND
BACKGROUND
Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of "Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management" (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial.
METHODS
METHODS
Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants-patients of an interprofessional primary care team-were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes.
RESULTS
RESULTS
Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (
CONCLUSIONS
CONCLUSIONS
Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT02715791. Registered 22 March 2016-retrospectively registered.
Identifiants
pubmed: 31673398
doi: 10.1186/s40814-019-0504-8
pii: 504
pmc: PMC6815451
doi:
Banques de données
ClinicalTrials.gov
['NCT02715791']
Types de publication
Journal Article
Langues
eng
Pagination
118Informations de copyright
© The Author(s). 2019.
Déclaration de conflit d'intérêts
Competing interestsThe authors declare that they have no competing interests.
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