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: www.pactr.org
Trial no.: PACTR201801002959401 Date registered: 10/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of Training Community Health Workers and Their Interventions on Cardiovascular Disease Risk Factors among Adults in Morogoro, Tanzania
Official scientific title Effects of Training Community Health Workers and Their Interventions on Cardiovascular Disease Risk Factors among Adults in Morogoro, Tanzania
Brief summary describing the background and objectives of the trial Background: Cardiovascular diseases (CVDs) are increasingly contributing to morbidity and mortality in Tanzania. Public knowledge about cardiovascular disease risk factors (CVDRFs) is important for primary prevention of CVDs and can be improved through Community Health Workers (CHWs) interventions. Elsewhere, CVD prention interventions delivered by CHWs have shown to improve knowledge, self-management and behavior toward CVDRFs. However, evidence of improvement in knowledge and changes in CVDRFs following CHWs interventions is lacking in Tanzania. Broad objective: To assess effects of training CHWs and their CVD-specific interventions on knowledge and proportion of hypertension and other CVDRFs among adults in Morogoro, Tanzania. Specific objectives: 1. To assess changes in knowledge about hypertension and other CVDRFs following a training on CVD among CHWs in Kilombero and Ulanga districts in Morogoro region, Tanzania 2. To assess changes in knowledge about hypertension and other CVDRFs following CHWs home health education and healthy lifestyle promotion intervention among rural communities in Kilombero and Ulanga districts in Morogoro region, Tanzania 3. To assess changes in the proportion of hypertension and other CVDRFs following CHWs home health education and healthy lifestyle promotion intervention among rural communities in Kilombero and Ulanga districts in Morogoro region, Tanzania 4. To determine the outcome of the CHWs home health education and healthy lifestyle promotion intervention on 10-year risk for CVD event among rural communities in Kilombero and Ulanga districts in Morogoro region, Tanzania 5. To assess perceived quality and acceptability of the CHWs home health education and healthy lifestyle promotion intervention among rural communities in Kilombero and Ulanga districts in Morogoro region, Tanzania
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiovascular Disease Risk Factors,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2018
Actual trial start date 01/06/2018
Anticipated date of last follow up 30/06/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 3290
Actual target sample size (number of participants) 3290
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 Randomised Villages (clusters) with active CHWs will be randomized to intervention and control group using computer generated codes Study villages (clusters) and not individual participants will be randomized Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care 1645
Experimental Group CHW home screening, health education and healthy lifestyle promotion Every 6 months 18 months CHW will conduct home screening, health education and healthy lifestyle promotion in the selected intervention villages 1645
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Resident of study village Age 35 years and above Provided informed consent for participation Non-resident of study village Age below 35 years Bed-ridden Mental ill-health Inability or refusal to provide informed consent 35 Year(s) 100 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 22/12/2017 Senate Research and Publications Committee of the Muhimbili University of Health and Allied Sciences
Ethics Committee Address
Street address City Postal code Country
United Nations Road Dar es Salaam 65001 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Change in knowledge about hypertension and other CVDRFs among CHWs Before and after training
Primary Outcome Change in knowledge about hypertension and other CVDRFs in the community Baseline and at 18 months
Primary Outcome The difference in changes in mean knowledge score about hypertension and other CVDRFs between baseline and end-line surveys for intervention and control villages. Baseline and at 18 months
Primary Outcome The difference in changes in proportion of elevated blood pressure between baseline and end-line surveys for intervention and control villages. Baseline and at 18 months
Primary Outcome The difference in change in the proportion of individuals at high risk for CVD (10-year risk for CVD >30%) between baseline and end-line surveys for intervention and control villages. Baseline and at 18 months
Secondary Outcome Proportion of elevated blood glucose in the intervention and control villages Baseline and at 18 months
Secondary Outcome Proportion of overweight and obesity in the intervention and control villages Baseline and at 18 months
Secondary Outcome Proportion of smoking in the intervention and control villages Baseline and at 18 months
Secondary Outcome Proportion of alcohol drinking in the intervention and control villages Baseline and at 18 months
Secondary Outcome Proportion of physical inactivity in the intervention and control villages Baseline and at 18 months
Secondary Outcome Proportion of unhealthy dietary habits in the intervention and control villages Baseline and at 18 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ulanga district Ulanga Morogoro 22 United Republic of Tanzania
Kilombero district Kilombero Morogoro 263 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Community Health, Muhimbili University of Health and Allied Sciences United Nations Road Dar es Salaam 65001 Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Community Health, Muhimbili University of Health and Allied Sciences United Nations Road Dar es Salaam 65001 Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Prof. David Urassa Department of Community Health, MUHAS Dar es Salaam 65001 Tanzania
Dr. Marina Njelekela Department of Physiology, MUHAS Dar es Salaam 65001 Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alfa Muhihi selukundo@gmail.com 255784270590 Mwai Kibaki Road
City Postal code Country Position/Affiliation
Dar es Salaam 79810 Tanzania Management and Development for Health (MDH)
Role Name Email Phone Street address
Public Enquiries Alfa Muhihi selukundo@gmail.com 255784270590 Mwai Kibaki Road
City Postal code Country Position/Affiliation
Dar es Salaam 79810 Tanzania Management and Development for Health (MDH)
Role Name Email Phone Street address
Scientific Enquiries Alfa Muhihi selukundo@gmail.com 255784270590 Mwai Kibaki Road
City Postal code Country Position/Affiliation
Dar es Salaam 79810 Tanzania Management and Development for Health (MDH)
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result URL Hyperlinks Baseline Characters Participant Flow Adverse Events Outcome Measures Description
Link To Protocol
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/07/2018 pactr update Prevention Education /Training
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 05/07/2018 pactr update Other Circulatory System, Other