Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102729454417 Date of Approval: 09/02/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Health Extension Workers led home-based intervention on Hypertension management in northwest Ethiopia, 2021
Official scientific title Effect of Health Extension Workers led home-based intervention on Hypertension management in northwest Ethiopia, 2021:Cluster Randomomized controlled Trial
Brief summary describing the background and objectives of the trial In Ethiopia, hypertension is highly prevalent but poorly treated and controlled. Poor access to care and shortage of health care providers are major barriers. This study aims to evaluate effect of health extension workers led home-based intervention on clinical linkage, lifestyle and medication adherence, blood pressure change, and optimal BP control among patients with hypertension in northwest Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/03/2021
Actual trial start date 18/03/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 18/01/2022
Anticipated target sample size (number of participants) 456
Actual target sample size (number of participants) 456
Recruitment status Completed
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 Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health Etension Workers led Home based Intervention Individuals with high blood pressure/hypertension will receive Home Health Education, Healthy lifestyle promotion and behavioral counseling, and referral for clinical linkage to health facility every 2 months for 40 minutes. The intervention will be given for 9 months Home Health Education (HHE): The HEWs will provide individualized and family-based brief health education for all patients with hypertension through home-to-home visits. They will provide a brief explanation of what hypertension means and its major modifiable risk factors such as excessive salt, excessive alcohol drinking, unhealthy dietary habits, and psychosocial stress for the participants. This session will also include education about the chronic nature of the disease, possible complications of untreated and uncontrolled HTN, and the possible need for lifelong medications. The aim is to increase the knowledge and understanding of patients about the disease and the importance of attending chronic care. Healthy lifestyle promotion and behavioral counseling: Based on each patient’s case, HEWs will provide counseling on healthy dietary habits (such as consuming a diet rich in fruit, vegetables, and low-fat dairy products, low salt diet, use of vegetable cooking oil, and use of whole grains), reduction of excessive alcohol drinking or alcohol moderation, and regular BP check-ups. Health extension workers will use motivational and effective communication for behavior change to encourage participants to change unhealthy lifestyle behaviors. They will provide brief counseling assistance (BCA) for patients on healthy lifestyle modification using the fife A’s approach Ask, Advise, Agree, Assist, and Arrange Referral for clinical linkage to health facility: The HEWs will provide referral slip for patients with hypertension explaining the nature of the diseases, the reason for referral, and the importance of initiating treatment if eligible. Moreover, the HEWs will remind the participants to see the nearby health facility for treatment and care through home visit. Medication adherence counselling (if any): Health extension workers will teach participants about the purpose of using medications, the negative effects of non-adherence, and the positive effects of treatment 228
Control Group Usual care 9 months starting from recruitment The usual care will consist of existing services in the community provided by the HEWs without any additional training. Services include the usual home visits for maternal and child health service, malaria prevention and control, family planning services, and support households for environmental sanitation, latrine construction. Health extension workers in this group do not provide any of the intervention components described above, but if the patient specifically requested them, the HEWs will comply. 228 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligiblity criteria for participants: Adult population aged 25 years and more with newly diagnosed hypertension (130/80 mmHg and more averaged over two readings) during home based hypertension screening performed by trained HEWs and the data collectors; individuals who know their hypertension status but not engaged in hypertension care, and those engaged in hypertension care but defaulted will be eligible to evaluate the effect of HEWs led home based intervention on clinical linkage. Adult population with high BP identified during the home based hypertension screening and those linked but uncontrolled hypertension (130/80 mmHg and more averaged over two readings) are eligible for evaluating the effect of HEWs led home based intervention on lifestyle and medication adherence, blood pressure change, and blood pressure control. Eligiblity criteria for clusters: Clusters having at least two working health extension workers are eligible for the study and selected during home based hypertension screening. Pregnant women Patients with HTN requiring immediate hospitalization Patients who were/are on renal dialysis or transplant Patients participated in a previous CVD study Patients who had a history of heart attack, stroke, or congestive heart failure 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 93 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 31/08/2020 Institutional Ethical Review Board of University of Gondar
Ethics Committee Address
Street address City Postal code Country
Gondar, Ethiopia Gondar 0196 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Clinical linkage to hypertension care and 2. Change in mean systolic blood pressure and diastolic blood pressures At baseline, 3 month, 6 month and 9 month or at endline
Secondary Outcome (1) change from baseline in the proportion of hypertensive patients with lifestyle modification at the end of the intervention; (2) proportion of medication adherence at the end of the intervention; and (3) the proportion of optimal blood pressure control at 3, 6, and 9 months. for the first secondary outcome data measured at baseline and 9 months, for the second secondary outcome data collected at the end of the intervention, and for the last outcome it 3, 6, and 9 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
North Gondar Zone and Central Gondar Zone North Gondar Zone and Central Gondar Zone Gondar 0196 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Gondar Gondar, Ethiopia Gondar 0196 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gondar Gondar, Ethiopia Gondar 0196 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dr. Kassahun Alemu Gelaye Gondar, Ethiopia Gondar 0196 Ethiopia
Prof. Shitaye Alemu Balcha Gondar, Ethiopia Gondar 0196 Ethiopia
Prof. Tadesse Awoke Ayele Gondar, Ethiopia Gondar 0196 Ethiopia
Dr. Asmamaw Atnafu Ayalneh Gondar, Ethiopia Gondar 0196 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Destaw Fetene Teshome destaw.fetene@gmail.com +251918037193 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
Role Name Email Phone Street address
Public Enquiries Kassahun Alemu Gelaye kassalemu@gmail.com +251911752466 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Shitaye Alemu Balcha shitayea@yahoo.com +251986781998 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Tadesse Awoke Ayele tawoke7@gmail.com +251910173308 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
Role Name Email Phone Street address
Scientific Enquiries Asmamaw Atnafu Ayalneh asme2002@gmail.com +251918776945 Gondar, Ethiopia
City Postal code Country Position/Affiliation
Gondar 0196 Ethiopia University of Gondar
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) wiill be shared Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Data are available indefinitely at (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL 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