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.: PACTR202210685104862 Date of Approval: 26/10/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effects of nurse-led stroke telerehabilitation intervention in Ghana: A Pilot Study Protocol
Official scientific title Effects of nurse-led stroke telerehabilitation intervention in Ghana: A Pilot Study Protocol
Brief summary describing the background and objectives of the trial The prevalence of stroke continues to rise in low-middle income countries. This continual rise in stroke cases is a crucial call for increased accessibility to rehabilitation services. A one group pretest posttest design would be used to evaluate a nurse-led telerehabilitation intervention in improving self-efficacy of patients. Participants would undergo initial and continuous assessment for the identification problems and needs. Based on individual needs, participants would receive various nursing rehabilitation therapies in appropriate domains (cognitive, physical, emotional and nursing education) for 6months. A follow-up evaluation would be carried at 30-, 60- and 90-days after the intervention has ended
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2023
Actual trial start date
Anticipated date of last follow up 04/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Active, not 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nurse led telerehabilitation for stroke patient 3 sessions per week 6 months This project would offer stroke patients and their caregivers comprehensive nursing neurorehabilitation support aimed at improving their overall self-efficacy. The components of the intervention are guided by relevant literature, established guidelines 25-27 and has been reviewed by a panel of experts including two neuroscience nurses, two community health nurses, three neurologists, one stroke specialist, one physiotherapist and a stroke survivor. Patients would undergo assessment and receive various therapies in appropriate domains for 6months. A follow-up evaluation would be carried after 30-, 60- and 90-days post first encounter. The intervention would involve the following components; Initial and ongoing patient assessment Participants would undergo various assessments on motor function, communication capacity, nutritional status, level of concentration, mood, and behavioural state utilising evidenced-based assessment tools29-30. Based on the problems and needs identified during assessment, participants would undergo 1 hour to 1 hour 30 minutes of sessions targeted at cognitive rehabilitation, physical rehabilitation, emotional support, fatigue management, and stroke education. Cognitive rehabilitation This domain is mainly focused on supporting participants to establish a routine and improving memory and attention. We would guide participants in clearly structuring their daily activities based on their preferences and setting priorities.9 Participants would also be aided in identifying memory strategies and how to utilise them for everyday activities.31 Physical rehabilitation The aim of physical rehabilitation will be the recovery of the patient's motor functioning affected by the stroke.8 The rehabilitation will mainly focus on regaining optimal use of the limbs affected through gait and mobility training, range of motion exercises, and upper limb therapies including constraint-induced therapy. Participants and their families will also be educated on acti 20
Control Group Standard rehabilitation management Participants in control group would receive treatment as usual (TAU) which comprise of two weekly physiotherapy sessions and two sessions with a medical doctor. 6 months Standard rehabilitation management offered by University of Ghana Hospital 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(1) is 18years or above\ (2) had a stroke with an onset of 1 week to 12 months prior to the intervention (3) has FIM score of 55-100 (Level 3 moderate assistance) (4) total NIHSS score of 5 - 15 (moderate stroke). However, study participants would be excluded subject to these criteria (1) has no access to a smartphone (2) is unavailable for follow-up interviews (3) has cognitive impairment that makes it difficult to comprehend information provided Adult: 19 Year-44 Year 18 Year(s) 60 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 02/02/2022 Noguchi Medical Research Institute
Ethics Committee Address
Street address City Postal code Country
GA-337-9818 Accra GA337 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Self-efficacy: The secondary and clinical outcome in focus would be Stroke Self-efficacy. The goal is assessed potential effectiveness of the intervention in improving self-efficacy among patients. This would be measured the Stroke Self Efficacy Questionnaire (SSEQ). The SSEQ is a 13-item scalar questionnaire that measures the stroke survivor’s ability and confidence in performing tasks under self-care, mobility and effective coping. The scale is also vital for assessing the functional performance of the study participants after the intervention. This tool is most appropriate because it has been proven to have good face validity with a Cronbach Alpha of 0.90 suggesting good internal consistency and higher criterion validity when compared with other self-efficacy scales. Baseline, 30, 90 days post intervention
Primary Outcome Based on the CONSORT checklist33 the pilot study is primarily aimed at assessing the preliminary feasibility and acceptability of the intervention in the Ghanaian context. Feasibility: Feasibility would be measured by retention rate, rate of adverse events and recording the details of resources used in implementing the intervention. Additionally, duration of sessions and cost of internet for the research team and study participants would be captured. Participant satisfaction: This will include the use of a 12-item questionnaire to assess the level of satisfaction of participants on delivery of the intervention, time spent, quality of audio-visual channels involved and overall perceived benefits.34 Participant experiences: Qualitative data of participant experiences would be captured in order to provide in-depth explanation of satisfaction levels. This would be guided by an interview probe designed for purpose. 30 days, 60 days and 90 days after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ghana Hospital Aywug007 Accra GA488 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
World Innovation Summit for Health Education City Doha Qatar
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Innovation Summit for Health Education City Doha-Qatar Education city Qatar Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Stephanopoulos Osei skjosei@st.ug.edu.gh +233559173392 GA-492-4263
City Postal code Country Position/Affiliation
Accra Ghana Graduate
Role Name Email Phone Street address
Public Enquiries Stephanopoulos Osei skjosei@st.ug.edu.gh +233559173392 University of Ghana
City Postal code Country Position/Affiliation
Accra Ghana Graduate
Role Name Email Phone Street address
Scientific Enquiries Lillian Ohene lohene@ug.edu.gh +233246395696 University of Ghana
City Postal code Country Position/Affiliation
Accra Ghana Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie reported results would be shared after deidentification (text, table,figures, appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately after publication till 2years after publication Researchers who have methodologically sound proposals may access the data
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