Clinical Trials Directory

Trials / Completed

CompletedNCT04618029

Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors

A Pilot Quasi-Experimental Study Evaluating the Feasibility and Potential Effectiveness of a Home Hazard Management Program on Reducing the Rate of Falls and Fear of Falling Among Malaysian Community Dwelling Stroke Survivors

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Universiti Putra Malaysia · Academic / Other
Sex
All
Age
45 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This quasi experimental design study aims to examine the feasibility and potential effectiveness of a home hazard management program to reduce the rate of falls and fear of falling among Malaysian community dwelling stroke survivors. This study will be conducted in three local government hospitals in central Malaysia.

Detailed description

This study is a pilot quasi experimental study which consists of two groups namely the intervention and control group. The experimental group will be implementing the suggested home modifications as well as education for functional performance in the homes. In addition, this study is a pilot study, therefore the feasibility of the intervention to be implemented in practice will be investigated. Other than that, this study also focuses on the outcomes from the results in which to analyse the effect of home assessment and modifications on rate of falls and fear of falling. The study location is at Hospital Selayang, Hospital UPM and Hospital Shah Alam. However, the intervention will be conducted at selected participants homes. Convenient sampling will be conducted as the sampling method for this study. Any participants that fulfil the inclusion criteria will be approach for participation. Information of potential participants will be retrieved from the appointment book or online appointment system as well as their medical records. The screening and recruitment of participants will occur on the same day as their appointment at the hospital by a co-investigator at site. Prior to participating, all participants are required to fill up a written consent form. The co-investigator at site will approach the participants and explain in detail about the study. Information regarding the study, the risk and benefits, confidentiality, withdrawal from the study and questionnaires will also be conveyed. Participants will also be informed that they will not be paid for their participation, but they will receive a certificate of appreciation. Potential participants will be allowed sufficient time to consider their participation in the study. Consented participants will be screened using the Modified Rankin Scale and the 6-item Cognitive Impairment Test and be invited to take part in the study. The participants will be conveniently located into two different groups, namely the intervention group and the control group. All participants will be given an appointment for an online telehealth session according to the participants appropriate time. The telehealth platform that will be used for this study is Coviu-an integrated and specialized telehealth platform which is HIPAA-compliant (https://www.coviu.com/). A falls diary will also be given to participants by email or mail to record any falls they encountered within 3 months after the initial assessment. The participants will then be re-assessed after the 3 months from the initial baseline assessments. During the 3 months follow up, the participants are re-assessed using the same initial baseline questionnaires. The falls dairy will also be collected via email for analysis. Recruitment of participants during the initial baseline assessment will stop once it has reached 30 participants. However, withdrawal participants will be replaced, until the required sample size is achieved. Hospital Selayang and Hospital Pengajar UPM is conveniently chosen as the hospital for the intervention group while Hospital Shah Alam is chosen for the control group. These hospitals are chosen because of its accessibility for the researchers.

Conditions

Interventions

TypeNameDescription
OTHERHome ModificationHome Modification Intervention Floor Provide recommendations to: * Fix the back of the rugs and mats with adhesive/heavy duty tape * Buy non-slip mats * Tie all cables with a proper cable tie Lighting Provide recommendations to: * Buy a torch light * To replace worn light bulbs * Buy a light switch Bathroom Provide recommendations to: * Buy a non-slip mat * Install a grab rail * Buy a commode chair for showering Stairways Provide recommendations to: • Fix an adhesive tape for stair contrast
OTHEREducationTechniques Description Energy Conservation * Take your time * Go to the toilet more often, so you don't have to rush * Use a nearby toilet: commode, different bathroom * Prepare ahead (e.g., toilet paper near, other items for toileting, etc.) * Adjust equipment before changing position * Avoid transfers when tired * Ask for help if you feel sick or especially tired * Allow time for eyes to adjust to change in lighting Task Simplification * Plan and organise workspaces to eliminate unnecessary steps, save time, energy and reduce fatigue. * Prioritise and plan activities, alternating between active and quiet jobs and include rest periods. Ergonomics * Proper positioning while doing tasks * Safe mobility around the home

Timeline

Start date
2021-01-01
Primary completion
2022-04-01
Completion
2022-05-01
First posted
2020-11-05
Last updated
2022-05-24

Locations

3 sites across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT04618029. Inclusion in this directory is not an endorsement.