Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors

NCT ID: NCT04618029

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2022-05-01

Brief 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

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment Group

1. Home Assessment and Modification A two-component individualized home hazards management program will be provided for each participant in the intervention group according to the results of the HOME FAST. Basic home safety strategies and basic modifications are developed and will be prescribed for this study according to the HOME FAST assessment (weeks et al. 2010)

2. Education Education on optimization of functional performance in the home will be provided via pamphlets on fall prevention, including energy conservation techniques (Chumbler et al., 2010), ergonomics (Edwards et al., 2019) and task simplification techniques (Wesson et al., 2013) will be provided. These techniques will also be provided for participants' caregivers.

Group Type: EXPERIMENTAL

Home Modification

Intervention Type: OTHER

Home 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

Education

Intervention Type: OTHER

Techniques 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

Controlled Group

1\. Standard Care The standard care defined for this study is any care that are provided from the respective hospital. This will include common therapies and interventions for stroke rehabilitation in general.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home Modification

Home 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

Intervention Type: OTHER

Education

Techniques 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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Stroke survivors who are 45 to 80 years old
• Being diagnosed with first-time or recurrent stroke within 24 months (American Heart Association, 2013)
• Has been discharged from in-patient wards and is living in the community
• Undergoing outpatient rehabilitation
• Slight disability to moderately severe disability according to the Modified Rankin Scale
• Able to walk for a minimum of 10 metres unsupported (with or without aid)
• Cognitively intact (score <8 on the 6-item Cognitive Impairment Test) and
• Able to speak and understand Malay or English. The researcher will again verify the criteria of the included participants.

Participants will be excluded if they have at least one of the following criteria:

• Bed-bound
• Clinically diagnosed dementia according to ICD-11 definition
• Major psychiatric illnesses or psychosis (i.e. schizophrenia, paranoia)
• Diagnosed with aphasia
• Medically unstable for example unstable angina or untreated fits,
• Pregnant and
• Participants who had a prior home assessment and modification will also be excluded.

Withdrawal Criteria:

• Patients who withdraw at any time of the study
• Patients who have a recurrent stroke during the time of study with a new Modified Rankin Scale of 5 or 6

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Husna Ahmad Ainuddin

Principal Investigator and Doctoral Student, Department of Rehabilitation, Faculty of Medicine and Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad Hibatullah Romli, PhD

Role: PRINCIPAL_INVESTIGATOR

UPM

Locations

Hospital Selayang

Selayang Baru Utara, , Malaysia

Hospital UPM

Serdang, , Malaysia

Hospital Shah Alam

Shah Alam, , Malaysia

Countries

Malaysia

Other Identifiers

NMRR-20-501-52933

Identifier Type: -

Identifier Source: org_study_id