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.: PACTR202303612823074 Date of Approval: 22/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Health Coaching on Hypertension Control among Primary Care Patients with Uncontrolled Hypertension in Egypt
Official scientific title Health Coaching for Hypertension Control among Hypertensive Patients Attending Primary Health Care Settings in Port Said Governorate
Brief summary describing the background and objectives of the trial Health coaching can improve the adherence to lifestyle modification among hypertensive patients. Studies on its effect on improving blood pressure control are limited in Egyptian primary health care (PHC) settings. This study was designed to assess the effectiveness of health coaching on self-care activities and blood pressure control in PHC patients with hypertension compared with usual care.
Type of trial CCT
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 Treatment: Other
Anticipated trial start date 01/07/2020
Actual trial start date 01/07/2020
Anticipated date of last follow up 24/11/2021
Actual Last follow-up date 24/11/2021
Anticipated target sample size (number of participants) 142
Actual target sample size (number of participants) 141
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
4109 Ethical committee at the faculty of medicine Suez Canal university Egypt
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Health coaching intervention Face-to-face health coaching was once every 2 months for 4 sessions at the study settings and was up to 20-30 minutes in length during their monthly treatment refill. Mobile health coaching sessions were 9 sessions and up to 15-30 minutes in length. 6 months In intervention group, the participants received health coaching sessions, and phone calls in addition to the usual care 70
Control Group Hypertension usual care Hypertension usual care every two months in follow up visits (3 visits) 6 months Hypertension usual care in medication refill visits in primary health care 71 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Individuals with uncontrolled hypertension (BP measurements ≥ 140/90 mmHg) Aged 18 years or more Had diagnosed with hypertension for at least 1 year Had received antihypertensive medication without change for 3 months Had accepted to participate in the study Patients who were pregnant woman Extremely ill patient (e.g. decompensated renal disease) Severe mental e.g., severe depression or dementia that could interfere with communication or comprehending questions Those had visual and hearing impairments that interfere with communication. Those patients had not completed the interview 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 81 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 24/02/2020 Suez Canal University Faculty of Medicine Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Ring road, Ismailia, Egypt Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure measurements below 140/90 mm Hg. After 6 months of intervention
Secondary Outcome Score of hypertension self-care activity level effects After 6 months of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
El Gawhara Centre Port Said universal health insurance centers Port Said Egypt
El Arab Certre Port Said universal health insurance centers Port Said Egypt
El Kuwait Unit Port Said universal health insurance centers Port Said Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the Principal Investigator Faculty of medicine, Suez canal university, Ring Road Ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Suez Canal University Ring Road, Faculty of Medicine, Suez Canal University Ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samar Abbas dr.samar_90@yahoo.com +201007932627 Ring Road, Faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Heba Nour hebanour20@hotmail.com +201025154383 Ring Road, Faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Hazem Elgamal hazemelgamal@yahoo.com +201097610255 Ring Road, Faculty of Medicine, Suez Canal University
City Postal code Country Position/Affiliation
Ismailia Egypt Suez Canal University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared immediately following publication, No end date. Data will be shared for researchers who provide a methodologically sound proposal. Proposal should be directed to dr.samar_90@yahoo.com Clinical Study Report,Informed Consent Form 12 months The principal investigator will decide the request data Data will be analyzed by the senior investigator or co-senior investigator
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