Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors

NCT04618029 | Completed DMC

• 1 other identifier: NMRR-20-501-52933
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

stroke; fall prevention; environmental modification

Outcome Measures

Primary Outcomes (3)

• Change from home hazards baseline at 3 months

  HOMEFAST is a 25-item form that evaluates the performance of individuals to perform activities safely in the home environment. It assesses seven aspects of use i.e. floors, furniture arrangements, lighting, bathrooms, kitchen storage, staircases and movements (Mackenzie, Byles \& Higginbotham, 2000). It has scientific evidence in terms of validity and reliability. It has been tested for senior citizens living in the community and can be used by senior citizens, or health professionals (e.g., job-rearing practitioners, social workers, nurses, health science practitioners and medical practitioners) and the public (Romli et al, 2018; Romli et al., 2017). The scores are "0" for Yes and "1" for No. All the scores will be added up to form 1 total score. The total score is 25. A higher score indicates a higher risk of falling. The assessment will be administered twice during the study trial.

  Initial baseline assessment and within 1 week after the 3 months intervention

• Change from falls efficacy baseline at 3 months

  The FES-I short form is a 7-item questionnaire of fall-related self-efficacy based on the Falls Efficacy Scale-International (16 items) (Kempen et al., 2008). It has a 4-Likert scale from 1 'not at all concerned' to 4 'very concerned'. Higher values indicate less fall-related self-efficacy (and more concern about falling). The internal and 4-week test- retest reliability of the Short FES-I is excellent (Cronbach's alpha 0.92, intra-class coefficient 0.83) and comparable to the FES-I. The correlation between the Short FES-I and the FES-I is 0.97 (Kempen et al., 2008). The FES-I short form has been translated in Malay and Mandarin and has good reliability and validity (Tan et al., 2018). The assessment will be administered twice during the study trial.

  Initial baseline assessment and within 1 week after the 3 months intervention

• Falls Diary

  The falls diary is the preferred method of falls monitoring (Lord, Sherrington, Menz, \& Close, 2007) as it enables falls to be recorded immediately after they have occurred, minimizing the chance of participants forgetting to report a fall. The falls diary includes a calendar for each month of the study (3 months). Participants will have to tick at each box of every day whether they have fallen or not. If they fall on a specific day, the is another page which the participants must detail out the date, activity, time during the fall and if they when to see the doctor after the fall.

  3 months within the intervention duration

Secondary Outcomes (4)

• Change from stroke recovery baseline at 3 months

  Initial baseline assessment and 1 week after the 3 months intervention

• Change from quality of life baseline at 3 months

  Initial baseline assessment and 1 week after the 3 months intervention

• Change from caregiver's burden recovery baseline at 3 months

  Initial baseline assessment and 1 week after the 3 months intervention

• Change from occupational performance baseline at 3 months

  Initial baseline assessment and 1 week after the 3 months intervention

Other Outcomes (4)

• Modified Rankin Scale

  Initial Baseline Assessment

• Feasibility Questionnaire

  within 1 week after the 3 months intervention

• Demographic Data

  Initial Baseline Assessment

Study Arms (2)

Treatment Group

EXPERIMENTAL

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.

Other: Home Modification; Other: Education

Controlled Group

NO INTERVENTION

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.

Interventions

Home Modification 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

Treatment Group

Education 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

Treatment Group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead

Study Sites (3)

Hospital Selayang

Selayang Baru Utara, 68100, Malaysia

Location

Hospital UPM

Serdang, 43400, Malaysia

Location

Hospital Shah Alam

Shah Alam, 40000, Malaysia

Location

MeSH Terms

Conditions

Stroke

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Muhammad Hibatullah Romli, PhD

  UPM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: * Different hospitals for the treatment and control group * Two independent assessor will be recruited for data collection and data analysis of outcomes
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Doctoral Student, Department of Rehabilitation, Faculty of Medicine and Health Sciences

Model Details: A quasi experimental parallel interventional study model in which there will be 2 groups, a treatment group and a controlled group.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 5, 2020
• Study Start: January 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)