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.: PACTR202301917477205 Date of Approval: 16/01/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title EFFECT OF MOTIVATIONAL INTERVIEW ON LIFESTYLE MODIFICATION AMONG PATIENTS WITH HYPERTYENSION ATTENDING THE FAMILY MEDICINE CLINICS OF ISTH, IRRUA, NIGERIA – A RANDOMISED CONTROL TRIAL
Official scientific title EFFECT OF MOTIVATIONAL INTERVIEW ON LIFESTYLE MODIFICATION AMONG PATIENTS WITH HYPERTYENSION ATTENDING THE FAMILY MEDICINE CLINICS OF ISTH, IRRUA, NIGERIA – A RANDOMISED CONTROL TRIAL (MILMAPH STUDY)
Brief summary describing the background and objectives of the trial Background: Hypertension is a leading cause of morbidity and mortality globally. Over a quarter of patients with hypertension have uncontrolled hypertension. Lifestyle modification has been shown to improve blood pressure control, thus measures that would help patients with hypertension achieve positive lifestyle modification would improve BP control. The aim of the study is to determine the effect of motivational interview on lifestyle modification and blood pressure control among patients with hypertension attending the Family Medicine Clinics of Irrua Specialist Teaching Hospital (ISTH), Irrua, Nigeria. Methods: The study will be a randomised control trial. About 110 adults 18 years and above with hypertension presenting to the Family Medicine Clinics of ISTH will be randomised into intervention and control groups. The intervention group will be given motivational interview (MI) on lifestyle modification at the start of the study and monthly for a period of 6 months. The control group will be given standard care for the management of hypertension without MI and seen monthly for 6 months. Both groups will be assessed at baseline and 6 months. At baseline, qualitative technique will be used to determine the reason for not adopting lifestyle modification. Study Outcome: Primary outcome shall be lifestyle modification at 6 months while secondary outcome shall be blood pressure control at 6 months. Conclusion: Findings from the study will provide cost effective ways of blood pressure control and reduction in the disease burden of hypertension in Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MILMAPH
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 02/03/2023
Actual trial start date 03/05/2023
Anticipated date of last follow up 31/10/2023
Actual Last follow-up date 17/11/2023
Anticipated target sample size (number of participants) 110
Actual target sample size (number of participants) 250
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Motivational Interview At Baseline and monthly 6 months Patients will have sessions of Motivational Interview at baseline and monthly. The MI sessions will last for an average of 20 minutes and sessions will be about health-promoting lifestyle choices: • Physical Activity, • Healthy Diet, • Alcohol reduction/cessation, • Avoidance of smoking, • Ensuring adequate Sleep and • Reducing Stressful Activity and engaging in meditation, prayers, relaxation etc. This will be in addition to receiving standard care for the management of hypertension such as counselling and pharmacotherapy. 125
Control Group None None Patients will receive standard care for hypertension and will be seen monthly 6 Months Subsequent initiation of drug therapy and lifestyle counselling at baseline and during follow-up visits will be given to all participants as the standard care. That is, all the participants will continue to have their standard care, then to be followed up monthly for six months. Participants will be assessed at baseline and at 6 months. 125 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Adult patients aged 18 years and above. 2. Patients with diagnosed hypertension on antihypertensive medications for a period of not less than six months. 3. Patients who are antihypertensive-naïve but with BP greater than or equal to 140/90 mm Hg taken at least twice, 10 minutes apart. 1. Patients with cognitive impairment who may not be able to understand or comprehend well. 2. Physical disability that would limit patients from exercising. 3. Severely ill patients whose conditions would not allow them to be interviewed on review dates. 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) 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 07/03/2023 ISTH Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Km 87 Benin Auchi Expressway Irrua 310115 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lifestyle modification 6 Months
Secondary Outcome 2. Mean BP control (<140/90mmHg) 6 Months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Family Medicine Clinic Department of Family Medicine Irrua Specialist Teaching Hospital Km 87 Benin Auchi Road Irrua 310115 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Tertiary Education Trust Fund No 6 Zambezi Crescent, Off Aguiyi Ironsi Street, Maitama Abuja 900271 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tijani Idris Ahmad Oseni Department of Family Medicine, Ambrose Alli University Ekpoma 300001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tijani Oseni tijanioseni@aauekpoma.edu.ng +2348036281897 Km 13 Benin Auchi Road
City Postal code Country Position/Affiliation
Ekpoma 300001 Nigeria Lecturer Department of Family Medicine Ambrose Alli University Ekpoma Nigeria
Role Name Email Phone Street address
Public Enquiries Tijani Oseni tijanioseni@aauekpoma.edu.ng +2348036281897 Km 13 Benin Auchi Expressway
City Postal code Country Position/Affiliation
Ekpoma 300001 Nigeria Lecturer Department of Family Medicine Ambrose Alli University Ekpoma Nigeria
Role Name Email Phone Street address
Scientific Enquiries Tijani Oseni tijanioseni@aauekpoma.edu.ng +2348036281897 Km 13 Benin Auchi Expressway
City Postal code Country Position/Affiliation
Ekpoma 300001 Nigeria Lecturer Department of Family Medicine Ambrose Alli University Ekpoma Nigeria
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 shared. Clinical Study Report,Study Protocol IPD will be available 10 months after study completion Anybody on request
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