Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201606001671335 Date of Approval: 09/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Home based follow-up care among hypertensive patients attending a teaching hospital in Ilorin, Nigeria
Official scientific title The Impact of home based follow-up care intervention on hypertensive patients attending a teaching hospital in Ilorin, Nigeria
Brief summary describing the background and objectives of the trial The consequence of the increasing hypertension prevalence among Nigerian population is that it overwhelms the health system, reduces the quality of care, increases the cardiovascular risk; and the mortality. Furthermore, the asymptomatic nature of hypertension and high cost of care for patients are usually important factors for non-compliance with medication and drop-out (default) from treatment follow-up. The standard long term care for hypertensive patient is important for better clinical outcomes for hypertensive patients in Nigeria. However, the reality is that most of the impediments to hypertensive care as observed in Nigeria may not be totally addressed in a conventional hospital setting. This is because of attendant formality and busy schedule of Physicians which usually affect standard and quality of care at the hospital setting. Therefore, there is need to bring the health care services closer to the patients in the community to garner social support for their treatment and allow task shifting practices. Home based care management concept (which is adopted for this study) is becoming popular in medical science because of the need to increase access to medical care, reduce the health facilities work load, simplify disease management strategies, reduce the cost of managing diseases and remove other deterrents to treatment adherence. This study thereby developed, implemented and assessed the home based follow-up care intervention among randomized hypertensive patients attending outpatients¿ clinics of a teaching hospital in Ilorin, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HBFC
Disease(s) or condition(s) being studied Hypertension,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 07/09/2015
Actual trial start date 07/09/2015
Anticipated date of last follow up 28/10/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 299
Recruitment status Closed to recruitment,follow-up continuing
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 Randomised Allocation sequence was carried out by the independent Biostatistician who generated a random numbers of 2 coded outcomes for sequence numbers 001 to 299 using using simple random numbers generated from SPSS version 22 software. Allocation was thereafter determine by the Biostatitian who is located off the site and is contacted each time a patient is recruited. He therefore gave the code number through a phone call. Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Home based follow-up Care (HBFC) intervention monthly home based follow-up visit 12 months The 5 cardinal components of HBFC administered during the study were; 1. Visiting patients at their home or preferred place using task shifting approach 2. Medical history and Physical examination 3. Home based BP and BMI monitoring 4. Lifestyle modification and medication Adherence assessment 5. Hypertension Health Education and Counseling Session (HECS) and Adherence Counseling. 149
Control Group Usual Care At the discretion of the managing team in the clinics 12 months Allow to continue with the usual standard hospital care 150 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.All patients with essential (primary) hypertension attending outpatients clinic of UITH, Ilorin, Nigeria 2.Hypertensive patient of 40 years of age and above 3.Both newly diagnosed and old patients on treatment for hypertension 1.Patients on any form of health insurance scheme 2.Patient living outside the 3 local government areas of Ilorin metropolis. 3.Patients with clinically established Target Organ danmage or established cardiovascular disease. 4.Those hypertensive patients that are temporary residents in Ilorin 40 Year(s) 120 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 22/09/2015 University of Ilorin Teaching Hospital Ethical Research Committee
Ethics Committee Address
Street address City Postal code Country
Old Jebba road, Oke-ose Ilorin 240001 Nigeria
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 23/06/2015 Universiti Putra Malaysia Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Selangor Darul Ehsan Serdang 43400 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood pressure, BMI, Medication adherence, Blood Lipids, Blood glucose, 6 months 12 months
Secondary Outcome Health related quality of life 6 months 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin, Teaching Hospital Oke-ose, Ilorin 240001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Nigerian Tertiary Education Trust Fund (TETFund) 6, Zambezi Crescent, off Aguiyi Ironsi street, Maitama Abuja Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nigerian Tertiary Education Trust Fund (TETFund) 6, Zambezi Crescent, off Aguiyi Ironsi street, Maitama Abuja Nigeria Funding Agency
COLLABORATORS
Name Street address City Postal code Country
Prof Hanafiah Bin Juni Department of Community Health, UPM Serdang Malaysia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Oladimeji Bolarinwa drdeji@yahoo.com +2348035147130 Department of Epid & Community Health
City Postal code Country Position/Affiliation
Ilorin 240001 Nigeria Senior Lecturer/University of Ilorin
Role Name Email Phone Street address
Public Enquiries Tanimola Akande akandetm@yahoo.com +2348034060179 Department of Epid & Community Health
City Postal code Country Position/Affiliation
Ilorin 240001 Nigeria Professor/University of Ilorin
Role Name Email Phone Street address
Scientific Enquiries Muhamad Hanafian hanafiah_juni@upm.edu.my +60389472425 Department of Community Health, UPM
City Postal code Country Position/Affiliation
Serdang 43400 Malaysia Professor/Universiti Putra Malaysia
REPORTING
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Result URL Hyperlinks
Changes to trial information