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.: PACTR202212690725065 Date of Approval: 21/12/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Development and evaluation of a public health center-based culturally tailored hypertension self-care intervention (CTHSI) among adults in rural Ghana
Official scientific title Development and evaluation of a public health center-based culturally tailored hypertension self-care intervention (CTHSI) among adults in rural Ghana
Brief summary describing the background and objectives of the trial PROTOCOL SUMMARY Background: The increasing problem of hypertension globally contributes significantly to the non-communicable disease burden, with a worse impact in developing countries. Policymakers and health care practitioners must institute public health center-based measures to ensure comprehensiveness of care by using cost-effective and efficient innovation strategies for care, improved health literacy, and reduced related complications. Coordinated implementation of self-care interventions must be directed to public health centers by leveraging the critical role of CHNs in disease prevention and control. Objective: This study aims to develop and evaluate the effectiveness of a CHPS-based nurse-led Culturally Tailored Hypertension Self-care Intervention (CTHSI) for rural community residents with uncontrolled hypertension compared to usual care. Methods: The methodology section of this study is considered under two broad sections 1) the development of the hypertension self-care intervention and 2) testing the efficacy of the hypertension self-care intervention. The intervention was developed by adopting the intervention mapping approach. The CTHSI intervention module will be simplified into a hypertension self-care intervention guide encompassing six main sessions. The modules include 1) health literacy, 2) adherence to therapy, 3) continuous monitoring, 4) reduction of the modifiable risk factors of hypertension, 5) Self-care management strategies, and 6) Strategies for sustaining behavior. This study will use a single-blinded non-randomized quasi-experimental pilot trial at three-time points. The unit of randomization for implementation of the CTHSI will be the CHPS facilities The study population will involve people between 40 and 60 years with uncontrolled blood pressure (systolic BP≥140 mmHg and/or a diastolic BP≥90mmHg) residing in the Bunkpurugu Nakpanduri district. Posters, local community announcements, and an announcement during home visiting by CHNs
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 27/01/2023
Actual trial start date
Anticipated date of last follow up 12/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
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 Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Culturall Tailored Hypertension Selfcare Intervention CTHSI Eight weeks, weekly intervention sessions 8 Weeks Cultural Tailored Hypertension Self Care intervention The developed model, referred to as the CTHSI, was focused on the process dimension of self-care while the primary outcome is to lead to BP control by targeting and eliminating the associated factors. The process dimension is a critical point where self-care interventions can be instituted, especially in chronic diseases (Riegel et al., 2018). The secondary outcome that directly influences BP control is hypertension self-care behavior. Incorporating the identified factors in the self-care theory was appropriate for influencing health care behavior in local rural communities (Jaarsma et al., 2017; Riegel et al., 2018). The CTHSI primary demonstrate how to implement the Riegel self-care model in managing hypertension among rural residents. 18
Control Group Receive usual Hospital based care No intervention 8 weeks The control group will receive the usual care as currently implemented by the GHS. Hypertension patients are diagnosed, receive conventional health education by a nurse in the consulting room with the doctor, are given a prescription (primarily for 30 days), are instructed to report any adverse observations, and are expected to return monthly for drug refill. After completing the eight weeks, the control group will also be given the CTHSI, as this intervention will be critical in improving their self-care behavior and promote better health outcomes. 18 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Diagnose to have uncontrolled or elevated BP for at least six months and have no other comorbidities (e.g., diabetes mellitus, kidney disease, hyperlipidemia, heart failure), 2) Self-reported to be on antihypertensive medication, and 3) Age range 40 to 60 years. 1) Patients with controlled BP (systolic BP≥140mmHg and diastolic BP≥ 90mmHg). 2) Mentally incapable (including any form of mental illness, e.g., bipolar disorder, schizophrenia, or cognitive impairment) of providing consent. 3) Incapable of comprehending to communication. 4) Pregnant or plans to be pregnant within three months from the commencement of the study. 5) Residents that will not be available throughout the study and/or reported not having adequate time to attend all weekly sessions. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 60 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
No 26/10/2022 University of Health and Allied Sciences Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ho, University of Health and Allied Sciences Ho PMB 31 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Reduction in Blood Pressure Week1, Week8 and Week12
Secondary Outcome Hypertension self-care behavior Week1, Week8, and week 12
Secondary Outcome Health literacy of Hypertension Week 1, Week 8 and week 12
Secondary Outcome Medication adherence self-efficacy Week 1, Week 8 and Week 12
Secondary Outcome Social support for hypertension patients Week1, week 8 and Week 12
Secondary Outcome Cultural belief in relation to hypertension self care behaviour Week 1, week 8 and week 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bunkpurugu Health Center Bunkpurugu Bunkpurugu P.O Box 2 Ghana
Nakpanduri Heath center Nakpanduri Nakpanduri P O Box 2 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Kennedy Diema Konlan Seodeamungu-gu Seoul 03722 Korea, Republic of
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kennedy Diema Konlan University of Health and Allied Sciences Ho PMB 31 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Hyeonkyeong Lee Yonsei University College of Nursing Seoul 03722 Korea, Republic of
Yeonsoo Jang Yonsei University College of Nursing Seoul 03722 Korea, Republic of
Seoung Eun Lee Yonsei University College of Nursing Seoul 03722 Korea, Republic of
Soyoon Kim Yonsei University, Graduate school of Public Health Seoul 03722 Korea, Republic of
Hong Hyechung Chung Ang University, College of Nursing Seoul Korea, Republic of
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kennedy Diema Konlan dkkonlan@uhas.edu.gh +8201043452811 University of Health and Allied Sciences
City Postal code Country Position/Affiliation
Ho PMB31 Ghana PhD Student
Role Name Email Phone Street address
Public Enquiries Kennedy Diema Konlan dkkonlan@uhas.edu.gh 8201043452811 Yonsei University, College of Nursing
City Postal code Country Position/Affiliation
Seoul 03722 Korea, Republic of PhD Student
Role Name Email Phone Street address
Scientific Enquiries Kennedy Diema Konlan dkkonlan@uhas.edu.gh +2330246392811 University of Health and Allied Sciences
City Postal code Country Position/Affiliation
Ho PMB31 Ghana PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be published only in scientific journals. When publishing any data from this study, the client specific identifiers will not be included, hence data cannot be traced to specific participants. The individual patient data will not be shared with any third party and will be used for academic purposes only. All data generated from this study will be under the custody of the principal investigator. Informed Consent Form,Statistical Analysis Plan,Study Protocol one year Open
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