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

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ClinicalTrials.gov Identifier: NCT03055468
Recruitment Status : Unknown
Verified March 2017 by Makerere University.
Recruitment status was:  Not yet recruiting
First Posted : February 16, 2017
Last Update Posted : March 13, 2017
Sponsor:
Information provided by (Responsible Party):
Makerere University

Brief 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).


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Depression Behavioral: Peer support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We will have an intervention and a control group.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Random sequence generation will be done by an independent biostatistician
Primary Purpose: Treatment
Official Title: Developing a Peer Support Model for Depression Care in Patients With Diabetes Mellitus, and Testing it's Efficacy on Patient Outcomes; a Randomized Control Trial Protocal
Estimated Study Start Date : April 1, 2017
Estimated Primary Completion Date : March 30, 2018
Estimated Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peer Support
Participants in this group will receive peer support as well as antidepressant medications comprised of either Fluoxetine 20mg O.D or Imipramine 75mg nocte.
Behavioral: Peer support
Peer support and antidepressant medications

Active Comparator: No Peer support
Participants will only receive antidepressant medications comprised of either Fluoxetine 20mg O.D or Imipramine 75mg nocte.
Behavioral: Peer support
Peer support and antidepressant medications




Primary Outcome Measures :
  1. Adequate glycaemic control [ Time Frame: 48 weeks after initiation into antidepressant treatment ]
    Adequate glycaemic control will be measured as a HbAIc score of <7

  2. Depression Clinical Remission [ Time Frame: 48 weeks after initiation into antidepressant treatment ]
    A HAM-D score of <17



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- All Patients with Diabetes Melitus who have been accessing care at the clinic for atleast 6 months

Exclusion Criteria:

  • Patients with overt psychiatric or physical illness for which emergency medical care is needed
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03055468    
Other Study ID Numbers: MakerereU
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Depression
Depressive Disorder
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders