Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807135104799 Date of Approval: 12/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECTIVENESS OF DEPRESSION MANAGEMENT ON NON-COMMUNICABLE DISEASES OUTCOMES IN MALAWI
Official scientific title Evaluating the effectiveness of depression management on gylcaemic control in non communicable diseases clinics in Malawi
Brief summary describing the background and objectives of the trial Depression is associated with negative patient outcomes for chronic diseases and likely affects consistent physical non-communicable diseases (NCDs) care management in relation to clinic attendance and medication adherence. We found no published studies on the integration of depression management in physical NCD clinics in Malawi and assessing its effects on patient and service outcomes. Therefore, the aim of this study is to evaluate the effectiveness of integrating depression screening and management in physical NCD routine care on patient and service outcomes in Malawi.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 174
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Usual Care Monthly The NCD clinicians treating patients with comorbid depression and diabetes using normal practices of treating depression involving antidepressants 87 Uncontrolled
Experimental Group Screenin combined with Medication Based Care and Problem Solving Therapy Monthly 1. Clinicians at the physical NCD clinics will be conducting routine screening for depression with a validated PHQ 9, 2. Clinicians at the physical NCD clinics will be coming up with individual care plans and prescribing and monitoring antidepressants for diabetic patients with comorbid depression 3. Clinicians at the physical NCD clinics will be using the effective helping techniques for problem solving in depression and make follow up on individual care plans. 87
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with comorbid diabetes and depression Consecutive patients aged 18 years and older will be eligible Both males and females Non consenting patients, Those less than 18 years Patients with an illness causing inability to talk Patients with severe illness requiring urgent attention 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 31/08/2017 College of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
John Chiphangwi Learning Resource Centre, College of Medicine-Mahtma Ghandi Campus, Mahatma Ghandi road, Blantyre, Malawi. Blantyre 00265 Malawi
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome for this study is blood glucose control and improving depression is the co-primary outcome. At baseline, 3 and 6 months.
Secondary Outcome Quality of life (QoL) At baseline, 3 and 6 months.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mchinji District Hospital Mchinji District Mchinji Malawi
Kasungu District Hospital Kasungu District Kasungu Malawi
Salima District Hospital Salima District Salima Malawi
Dedza District Hospital Dedza District Dedza Malawi
FUNDING SOURCES
Name of source Street address City Postal code Country
Wellcome Trust Gibbs Building, 215 Euston Road, London NW1 2BE, UK London United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor African Mental Health Research Initiative University of Zimbabwe Harare Zimbabwe Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Professor Adamson Muula College of Medicine, Blantyre Malawi
Associate Professor Brian Pence University of North Carolina North Carolina United States of America
Dr Robert Stewart College of Medicine Blantyre Malawi
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Udedi mphatsoudedi@yahoo.co.uk +265881613541 Capital Hill
City Postal code Country Position/Affiliation
Lilongwe Malawi College of Medicine
Role Name Email Phone Street address
Scientific Enquiries Adamson Muula amuula@medcol.mw +265884233486 College of Medicine
City Postal code Country Position/Affiliation
Blantyre Malawi College of Medicine
Role Name Email Phone Street address
Public Enquiries Robert Stewart robcstewart@mac.com +265994375287 College of Medicine
City Postal code Country Position/Affiliation
Blantyre Malawi Head of Mental Health Department
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information