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.: PACTR201511001358312 Date of Approval: 22/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title SMS and clinic appointments
Official scientific title The effect of short message service (SMS) reminders on subsequent clinic attendance among out-patients with first episode psychosis at a psychiatric hospital in Nigeria: A randomized trial
Brief summary describing the background and objectives of the trial To determine if short message service (SMS) reminders sent to patients with first-episode psychosis presenting for the first time at a regional tertiary psychiatric facility would improve attendance rates at their next scheduled clinic visit.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Mental Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2014
Actual trial start date 01/06/2014
Anticipated date of last follow up 30/11/2014
Actual Last follow-up date 30/11/2014
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randmisation using a randomisation table created by a computer software program Allocation was determined by the holder of the sequence whois situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SMS text messages two over 5 days short message service from an SMS bulk platform provider 100
Control Group Reminder Appointment Cards Once N/A Date of next appointment written on appointment card 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All new cases presenting at the Federal Neuro-Psychiatric Hospital, Benin City within the study period, with a first episode of a psychotic disorder as defined in the International Classification of Mental and Behavioural Disorders (ICD-10) coded by F20-F39 and confirmed on the M.I.N.I. 2. Patients aged between 18 and 64 years. 3. Patients and/or caregivers who gave consent to participate in the study. 4. Patients and/or caregivers who had a functional mobile phone, and could read and understand text messages in the English language 1. Patients who met the inclusion criteria but required admission for in-patient care. 2. Patients who met the inclusion criteria but had to be referred to another health facility due to co-morbidity. 3. Patients who presented to the hospital before their scheduled appointment because of deteriorating health state and/or subsequently required in-patient care. 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 05/02/2014 FNPH Benin-City Ethics & Research Committe
Ethics Committee Address
Street address City Postal code Country
Ugbowo Lagos Road Benin City 30001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measured was proportions of missed first clinic appointment. Date of scheduled clinic appointment
Secondary Outcome Effect of socio-demographic and clinicalcharacteristics on next scheduled appointments N/A
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Neuro-Psychiatric Hospital Ugbowo Lagos Road Benin City 30001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Author Funded
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Bawo James FNPH Benin City, Ugbowo Lagos Road Benin City 3001 Nigeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Felicia Thomas FNPH Benin City, Ugbowo Lagos Road Benin City 3001 Nigeria
Ambrose Lawani FNPH Benin City, Ugbowo Lagos Road Benin City 3001 Nigeria
Bawo James FNPH Benin City, Ugbowo Lagos Road Benin City 3001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Felicia Thomas ronke2k7@yahoo.com +234-7011150587 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City 30001 Nigeria Senior Registrar/Psychiatry
Role Name Email Phone Street address
Public Enquiries Ambrose Lawani ambroselawani@yahoo.com +234-8023452315 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City 30001 Nigeria Consultant Psychiatrist
Role Name Email Phone Street address
Public Enquiries Ambrose Lawani ambroselawani@yahoo.com +234-8023452315 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City 30001 Nigeria Consultant Psychiatrist
Role Name Email Phone Street address
Scientific Enquiries Bawo James bawojames@yahoo.com +234-8023715213 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City 30001 Nigeria Consultant Psychiatrist
Role Name Email Phone Street address
Scientific Enquiries Bawo James bawojames@yahoo.com +234-8023715213 Ugbowo Lagos Road
City Postal code Country Position/Affiliation
Benin City 30001 Nigeria Consultant Psychiatrist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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