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.: PACTR201908812642231 Date of Approval: 23/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Impact of Self-Care Education on Self-Care Adherence among Chronic Heart Failure Patients Attending at Debre Markos and Felege Hiwot Referral Referral Hospital Northwest Ethiopia,2018/19: a cluster Randomized Control Clinical Trial.
Official scientific title The Impact of Self-Care Education on Self-Care Adherence among Chronic Heart Failure Patients Attending at Debre Markos and Felege Hiwot Referral Referral Hospital Northwest Ethiopia,2018/19
Brief summary describing the background and objectives of the trial For good adherence well designed patient education program about self-care adherence is important. For instance the finding of study conducted in Auckland showed that these patients who were attend the education sessions, visit heart failure clinic, and who visit primary care, had a lower morbidity and mortality rate .The subset of patients who did not adopt self-management strategies were at high risk of death or readmission . This also true on Random-effects meta-analysis which found that mortality risk was 10.6% lower among HF patients who received medication adherence interventions when compared to control groups. Medication adherence interventions also reduced HF patients’ risk of hospitalization For good result the patients should be active partners with health professionals in their own care and that good communication between patient and health professional is a must for an effective clinical practice. Due to this facts strong emphasis was placed on the patient’s agreement to the self-care recommendations . Therefore, determining the impact of self-care programs on self-care adherence will pave the way to extend related programs to address the problem in the study area as well as in the country.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Not applicable
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/10/2017
Actual trial start date 01/01/2018
Anticipated date of last follow up 30/08/2019
Actual Last follow-up date 01/08/2019
Anticipated target sample size (number of participants) 228
Actual target sample size (number of participants) 188
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Training for four time duration every 2 month for one year for intervention group:-The self-care education program will be developed by a panel of experts based on Orem self-care deficit model. First, we will follow the clinical practice guidelines for HF patients. The materials will be developed using simple language at a primary school reading level, and each item will have associated graphics to reinforce understanding. The face validity of educational materials will have determined after a review provided by 7 experts which incorporates physicians, dieticians, Nurses, health educators and physiotherapists. Each participant during intervention phase will receive 5 day-long individualized based self-care training session and they will have follow up every two months at least for one year. 89
Control Group usual care 4 times every 2 month for 1 year Participants in the control group will receive the usual care which would customarily be administered to HF patients receiving treatment from the hospital. 99 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of HF age >18 years able to understand and sign written informed consent End-stage HF, patient who are transferred from other hospital 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 24/08/2017 Institutional research ethics review committee Debre Markos University College of Health Sciences
Ethics Committee Address
Street address City Postal code Country
debre markos Debre Markos 6000 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Self care Adherance 3 times every 3 month
Secondary Outcome no secondary outcome not aplicable
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos referal hospital Debre Markos Debre Markos 6000 Ethiopia
Feleg hiwot Referral Hospital Bahir Dar Bahir Dar 6000 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Debre Markos university Debre Markos Debre Markos Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Debre Markos University Debre Markos Debre Markos Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Dubie Jara Debre Markos Debre Markos 6000 Ethiopia
Girma Alem Debre Markos Debre Markos 6000 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Getenet Dessie ayalew.d16@gmail.com +251923522712 Bahir Dar
City Postal code Country Position/Affiliation
Bahir Dar 6000 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Henok Mulugeta mulugetahenok68@gmail.com +251913645701 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos 6000 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Dessalegn Haile dessalegnhaile@gmail.com +251913429647 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos 6000 Ethiopia Department Head
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes After data collection is completed ,we will share the summary results of individual participant data Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol December 15/2019 based on WHO criteria
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