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.: PACTR201802003029643 Date of Approval: 30/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The effect of phone call based brief adherence counselling (PC-BACS) on subsequent clinic attendance among outpatients with schizophrenia
Official scientific title The effect of phone call based brief adherence counselling (PC-BACS) on subsequent clinic attendance among outpatients with schizophrenia at the federal Neuropsychiatric Hospital, Benin city, Nigeria: a randomised controlled trial
Brief summary describing the background and objectives of the trial This trial will be conducted at the outpatients unit of the federal Neuropsychiatric hospital Benin city . Eighty six participants will be randomized into two equal groups A and B (43 per group). Participants in Group a will receive a text message reminding them of day, date, venue and time of their next clinic appointment viz " Good day. This is to remind you of your appointment/ appointment of your relative at the outpatient unit of Federal Neuropsychiatric Hospital at 8am on (date) via a bulk SMS platform. This will be sent on the 5th and 2nd day prior to the clinic visit. It will be send several times on those days to increase the chance of receiving the intervention. The SMS will be sent to both patients and their relative. In addition to the above, participants in group B will receive phone call based brief adherence counselling viz " I want to talk to you on some important facts about your illness/ the illness of your relative and its treatment. Firstly, the experiences you told me on your visit coupled with other symptoms your relative also mentioned show you have a serious psychological illness called schizophrenia. Schizophrenia is a disease of the brain. It is not " character flaw or spiritual attack " as some persons perceive it. You need to visit the clinic on your appointment date without fail. Attending clinic is beneficial because it allows you to meet with the doctors, express your complaints and worries about side effects or treatment you are receiving. The doctor will respond to all your concerns and pick important signs you did not complain about. Clinic visit will also help the doctor to assess your improvement and reduce your medications or suggest additional therapy. You will also have the opportunity to refill your medications. I will call your relative to assist you in making regular clinic appointment visits and to help monitor your medication taking. Do you have any questions?. Thank you"
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PC BACS trial
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Schizophrenia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 20/02/2018
Actual trial start date
Anticipated date of last follow up 22/02/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 86
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Participants will be randomly assigned to either the control group A or experimental group B in a simple randomization process with a 1:1 allocation as per a computer generated randomization schedule stratified by site (www.randomiser.org) Sealed opaque envelopes will be used to conceal the allocation sequence Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group phone call based brief adherence counselling and Short message service reminders only once throughout study duration About six minutes 43
Control Group Short message service reminders only SMS will be sent to participants and caregivers automatically on the 5th and 2nd day prior to clinic appointment ONCE, after the initial visit two minutes An SMS reminder will be sent to both participants and their relatives on the 5th and 2nd day prior to first clinic appointment. this will be sent only once. the case notes of the participants in this group will the be checked if they attended their clinic appointments for the next three clinic visits. The intervention will be given only once, prior to first clinic appointment 43 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All cases presenting to the Federal Neuropsychiatric Hospital Benin City within the study period diagnosed of schizophrenia as defined by the International Classification of Diseases 10th edition (ICD-10) and confirmed on the mini international Neuropsychiatric interview. Participants and caregivers who give consent to participate in the study. Patients and caregivers who have functional mobile phones and understand English language. Caregivers must live with the patient Patients/caregivers who do not possess a functional mobile phone or who live in an area where there is no mobile phone network coverage. Patients who meet inclusion criteria but require admission for inpatient care. Patient who meet inclusion criteria but require referral to another health facility due to co-morbidity. Patients who will present before their scheduled appointment because of deteriorating health state and/ or require admission. Patients who do not present in company of a caregiver 18 Year(s) 64 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 11/09/2017 Research and ethics committee of the federal Neuropsychiatric hospital
Ethics Committee Address
Street address City Postal code Country
Uselu-Lagos road, by Medical junction , beside GT Bank Benin City +234 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure will be the proportions of missed scheduled clinic appointments in the first visit after initial appointment 2-3 weeks after first hospital visit depending on booking slots available in the hospital's record department
Secondary Outcome The secondary outcome will be the proportions of missed clinic appointments in the 2nd and 3rd clinic visits every 4-6 weeks after the second hospital visits for two consecutive clinic visits.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Neuropsychiatric Hospital Uselu-Lagos road by Medical junction Uselu. . Benin City +234 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Erohubie Paul No 1 Ogbomo close, off vester ohenhen, off 19th street Ugbowo Benin City +234 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Erohubie Paul No 1 Ogbomo close, off vester ohenhen, off 19th street Ugbowo Benin City +234 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
James Bawo Uselu-Lagos road by Medical junction Uselu. . Benin City +234 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Paul Erohubie Ojpaulkings@yahoo.com 08067173149 No 1 Ogbomo close, off vester Ohenhen, off 19th street
City Postal code Country Position/Affiliation
Benin city +234 Nigeria Principal investigator
Role Name Email Phone Street address
Public Enquiries Joyce Omoaregba jomoaregba@yahoo.com 08023345948 Uselu-Lagos Road, by medical junction
City Postal code Country Position/Affiliation
Benin City Nigeria Consultant psychiatrist/ Assistant supervisor
Role Name Email Phone Street address
Scientific Enquiries Bawo O James bawojames@yahoo.com 08023715213 Ekai street, off Sapele Road
City Postal code Country Position/Affiliation
Benin City +234 Nigeria Consultant psychiatrist/ supervisor
REPORTING
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Result URL Hyperlinks
Changes to trial information