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.: PACTR202212839343068 Date of Approval: 15/12/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The role of routine home visits by community health workers
Official scientific title The role of CHW's home health visits on medication adherence among chronically-illed elderly
Brief summary describing the background and objectives of the trial Background of the study: This study is designed to understand the challenges regarding access of care, particularly those living in the rural area, and the effect of a potential intervention aiming at improving access. The intervention involves routine home visits by community health workers with basic health consultation, temperature check, blood pressure check, and providing a medication uptake schedule reminder.  Objectives of the study: To improve medication adherence also decrease/minimize unnecessary health care utilization.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT randomized control trials
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/05/2022
Actual trial start date 25/06/2022
Anticipated date of last follow up 13/11/2022
Actual Last follow-up date 13/11/2022
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 260
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://sites.google.com/view/abbiezhang/field-experiment-facts
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Routine home visits by volunteer social workers Routine home visits: once a month It includes: (1) providing hand-written medication uptake reminder table: once a month; (2) usage of a medication sorting box 6 Months Monthly home health visits that includes: (1) Social worker's communication with respondents to understand their needs, challenges in home health management; (2) providing hand-written medication uptake reminder table: once a month; (3) usage of a medication sorting box: once a month --Phone follow-ups: once a week reminder on medication uptake and health well-being check. 140
Control Group Phone call respondent by volunteer social workers Phone call respondent: once a month Phone follow-ups: once a week; it involves them their health information through the use of a questionnaire. 6 Months Monthly home health visits that includes: Social worker's communication with respondents to understand their needs, challenges in home health management 120 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosed with health conditions particularly diabetes and hypertension. Individuals whose age is 45 or above. Individuals attending medical clinics at Iringa referral hospital, St Theresa hospital, and Ipamba hospital. Individuals diagnosed with health conditions mentioned above but whose age is below 45. Individuals diagnosed with health conditions mentioned but attending medical clinics in other hospitals were also not included. individuals with other health conditions were not included. 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 90 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 22/04/2022 Office of the Vice Chancellor at Ruaha Catholic University
Ethics Committee Address
Street address City Postal code Country
Uhuru Road P.O. Box 774 Iringa 51108 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adherence of Medication: Whether missed any dose of medication in the past 4 weeks Every last week of the month during in person survey
Secondary Outcome Whether admitted to ER in the past 4 weeks. Whether had hospitalization in the past 4 weeks Whether refilled medication on time at at health facility in the past 4 weeks. Every last week of the month during in person survey
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Iringa regional referral hospital Utalii Rd Box 260, Iringa , 123 Street, Iringa, Tosamaganga P.O. Box 11, Iringa respectively. Iringa 51108 United Republic of Tanzania
St Theresa health center Wenda, Mseke P.O. BOX 618 Iringa District Iringa 51204 United Republic of Tanzania
Ipamba hospital Tosamaganga, Ipamba P.O. Box 11, Iringa District Iringa 51201 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
School of Economics Henan University Research and Development Fund Minlung Street at Donglou Zhai Kaifeng 475001 China
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor School of Economics at Henan University 1 Jinming Road Kaifeng 475004 China University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yilei Zhang zhangyl334@gmail.com +17348342689 Minlung Str., Donglou Zhai
City Postal code Country Position/Affiliation
Keifeng 475001 China Seniour Lecturer at Henan University
Role Name Email Phone Street address
Public Enquiries Samwel Mwigeka mwigeka82@yahoo.com +255718083005 Wilolesi, P.O.BOX 774
City Postal code Country Position/Affiliation
Iringa 51108 United Republic of Tanzania Assistant Lecturer at Ruaha Catholic University
Role Name Email Phone Street address
Scientific Enquiries Yilei Zhang zhangyl334@gmail.com +17348342689 Minlung Str., Donglou Zhai
City Postal code Country Position/Affiliation
Kaifeng 475001 China Seniour Lecturer at Henan University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during this trial after de-identification (text, tables, figures and appendices). Analytic Code,Informed Consent Form,Statistical Analysis Plan Immediately Study Protocol: April 1st 2022 (for 36 months) Statistical Analysis Plan: July 1st 2022 (for 36 months) Analytic Code: September 2022 (for 36 month) Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. Proposals should be directed to zhangyl334@gmail.com to gain access.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data will be available at the link to be included later 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