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The Efficacy of Peer Support Model for Depression Care in Patients With Diabetes Mellitus

NCT03055468 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2017-03-13

No results posted yet for this study

Summary

Introduction: The prevalence of Diabetes Mellitus (DM) is on the rise the world over. About 30% of DM patients suffer from Depression. Depression in DM patients is associated with adverse outcomes including poor medication adherence, poor glycaemic control, and early death. In resource constrained sub-Saharan Africa (SSA) clinics where patient volumes are high and staff shortages rife, peer support has been suggested as a means of delivering psychosocial care for persons with chronic illnesses in order to improve patient's outcomes. However, little has been done to examine the efficacy of peer support on clinical outcomes.

Project aims: The main study objective will be developing a peer support model of depression care for patients with DM and testing its efficacy on clinical outcomes.

Methods: This study will employ both qualitative and quantitative measures. First, the investigators will present the peer support model to health workers within the DM clinic, and ask them about the feasibility of using such a model for DM patients with depression. The investigators will then identify 10 DM patients with major depression and initiate them on antidepressants. Once the patients are in clinical remission, the investigators will interview them to assess their perceptions about the feasibility of using peer support for DM patients newly diagnosed with depression. The investigators will also interview health care workers and hospital administrators to assess their perception about using peer support within the clinics, and potential barriers that need to be addressed before implementation of the model.

Based on the data from the qualitative interviews, the investigators will refine and adapt the peer support model, and then train 10 DM patients who have received antidepressants and are in clinical remission to deliver peer support to newly diagnosed patients with depression. Newly diagnosed depressed patients will be randomly assigned to receive either antidepressants plus peer support (n=65) or antidepressants alone (n=65). Study participants will be followed for 48 weeks and assessed for, glycaemic control, depression severity, mental illness stigma, depression treatment uptake and adherence.

Result: the investigators anticipate that the findings about the efficacy of peer support on DM and depression outcomes will be useful in generating data about effect sizes necessary for calculating a sample size for a cluster randomized trial (CRT).

Conditions

  • Diabetes Mellitus
  • Depression

Interventions

BEHAVIORAL

Peer support

Peer support and antidepressant medications

Sponsors & Collaborators

  • Makerere University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2018-03-30
Completion
2018-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03055468 on ClinicalTrials.gov