A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes.
diabetes
randomized controlled trial
unmet social needs
Journal
Journal of general internal medicine
ISSN: 1525-1497
Titre abrégé: J Gen Intern Med
Pays: United States
ID NLM: 8605834
Informations de publication
Date de publication:
11 Mar 2024
11 Mar 2024
Historique:
received:
06
09
2023
accepted:
27
02
2024
medline:
12
3
2024
pubmed:
12
3
2024
entrez:
12
3
2024
Statut:
aheadofprint
Résumé
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management. Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care. Randomized trial from 2019 to 2023. A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care. CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes. Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups. Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (p = 0.24). There were also no significant between-group differences in systolic blood pressure (p = 0.29), met social needs (p = 0.25), CRN (p = 0.18), and perceived financial burden (p = 0.31). In subgroup analyses, participants with household incomes 100-400% FPL (1.93 (SE = 0.76), p < 0.01), 201-400% FPL (1.30 (SE = 0.62), p < 0.04), and > 400% FPL (1.27 (SE = 0.64), p < 0.05) had significantly less A1c decreases compared to the control group. On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups. ClinicalTrials.gov ID NCT03950973, May 2019.
Sections du résumé
BACKGROUND
BACKGROUND
Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management.
OBJECTIVE
OBJECTIVE
Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care.
DESIGN
METHODS
Randomized trial from 2019 to 2023.
PARTICIPANTS
METHODS
A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care.
INTERVENTION
METHODS
CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes.
MEASURES
METHODS
Primary outcome was HbA1c, measured at baseline, and 6 and 12 months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups.
RESULTS
RESULTS
Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (p = 0.24). There were also no significant between-group differences in systolic blood pressure (p = 0.29), met social needs (p = 0.25), CRN (p = 0.18), and perceived financial burden (p = 0.31). In subgroup analyses, participants with household incomes 100-400% FPL (1.93 (SE = 0.76), p < 0.01), 201-400% FPL (1.30 (SE = 0.62), p < 0.04), and > 400% FPL (1.27 (SE = 0.64), p < 0.05) had significantly less A1c decreases compared to the control group.
CONCLUSIONS
CONCLUSIONS
On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups.
CLINICAL TRIALS REGISTRY
BACKGROUND
ClinicalTrials.gov ID NCT03950973, May 2019.
Identifiants
pubmed: 38467918
doi: 10.1007/s11606-024-08708-8
pii: 10.1007/s11606-024-08708-8
doi:
Banques de données
ClinicalTrials.gov
['NCT03950973']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : NIDDK NIH HHS
ID : R01 DK116715-01A1
Pays : United States
Organisme : NIDDK NIH HHS
ID : P30DK092926
Pays : United States
Informations de copyright
© 2024. The Author(s), under exclusive licence to Society of General Internal Medicine.
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