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.: PACTR202310710523197 Date of Approval: 20/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Development and Feasibility Testing of a Remote Support Application for Adherence to Home Exercise Programmes: A Pilot Study
Official scientific title Development and Feasibility Testing of a Remote Support Application for Adherence to Home Exercise Programmes: A Pilot Study
Brief summary describing the background and objectives of the trial Interventions in rehabilitation practice are traditionally structured to be delivered face-to-face to the patients. However, their benefits are largely depended on sustained patients’ participations, thus the need for home exercise programmes (HEPs). Unfortunately, despite the proven benefits of HEPs, the rate of non-adherence to the HEPs interventions is very prevalent. Remote monitoring is one of the recent innovations that is believed may help improve adherence and also provide feedback. However, data on feasibility and effectiveness of these remote applications in improving adherence to HEPs are still limited. This study was aimed to develop and test the feasibility of a remote support application for adherence to HEPs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/06/2021
Actual trial start date 15/06/2021
Anticipated date of last follow up 13/09/2021
Actual Last follow-up date 13/09/2021
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 19
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional paper handouts Daily for four weeks Four weeks Administering Home exercise programmes using traditional paper handouts for patients receiving physiotherapy for musculoskeletal conditions 9 Active-Treatment of Control Group
Experimental Group Remote Support Application Daily for four weeks Four weeks Customized home exercise programmes reminders via the Remote Support Application for patients receiving physiotherapy for musculoskeletal conditions 10
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with a musculoskeletal dysfunction, Patients that are 18 years and older, Patients having a physiotherapist prescribing home exercise programmes. Patients with any cognitive impairment. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 15/06/2021 Ethics and research Committee
Ethics Committee Address
Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Osogbo 220005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mobile Application Rating Scale 2nd week, 4th week
Secondary Outcome System Usability Scale Questionnaires 2nd week, 4th week
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospitals Complex Ile-Ife Osogbo 220005 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chidozie Mbada Obafemi Awolowo University Osogbo 220005 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chidozie Mbada Obafemi Awolowo University Osogbo 220005 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chidozie Mbada cembada@oauife.edu.ng +2348028252543 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries John Makinde mankindseun2@gmail.com +2348165801044 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Researcher
Role Name Email Phone Street address
Scientific Enquiries John Makinde mankindseun2@gmail.com +2348165801044 Obafemi Awolowo University
City Postal code Country Position/Affiliation
Osogbo 220005 Nigeria Clinical Researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available. Individual participant data that underline the results reported in this article, after deidentification (text, tables, figures and appendices) will be shared. Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Researchers who provide a methodological sound proposal to achieve aims in the research proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/10/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/10/2023 Result - 14/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information