The Efficacy of Peer Support Model for Depression Care in Patients With Diabetes Mellitus
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
1 other identifier
interventional
130
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Apr 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2017
CompletedFirst Posted
Study publicly available on registry
February 16, 2017
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2018
CompletedMarch 13, 2017
March 1, 2017
12 months
February 9, 2017
March 10, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Adequate glycaemic control
Adequate glycaemic control will be measured as a HbAIc score of \<7
48 weeks after initiation into antidepressant treatment
Depression Clinical Remission
A HAM-D score of \<17
48 weeks after initiation into antidepressant treatment
Study Arms (2)
Peer Support
EXPERIMENTALParticipants in this group will receive peer support as well as antidepressant medications comprised of either Fluoxetine 20mg O.D or Imipramine 75mg nocte.
No Peer support
ACTIVE COMPARATORParticipants will only receive antidepressant medications comprised of either Fluoxetine 20mg O.D or Imipramine 75mg nocte.
Interventions
Eligibility Criteria
You may qualify if:
- \- All Patients with Diabetes Melitus who have been accessing care at the clinic for atleast 6 months
You may not qualify if:
- Patients with overt psychiatric or physical illness for which emergency medical care is needed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Random sequence generation will be done by an independent biostatistician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2017
First Posted
February 16, 2017
Study Start
April 1, 2017
Primary Completion
March 30, 2018
Study Completion
March 30, 2018
Last Updated
March 13, 2017
Record last verified: 2017-03