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Completed

NCT Number: NCT04618029

Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Selayang, Selayang Baru Utara, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

The inclusion criteria will consist the following:

  • 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

Treatment and study plan

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

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

Primary outcomes

  1. Change from home hazards baseline at 3 months

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

    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.

  2. Change from falls efficacy baseline at 3 months

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

    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.

  3. Falls Diary

    Time frame: 3 months within the intervention duration

    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.

Secondary outcomes

  1. Change from stroke recovery baseline at 3 months

    Time frame: Initial baseline assessment and 1 week after the 3 months intervention

    Stroke Impact Scale is a 59-item measure that covers 8 domains namely strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking and participation (Duncan et al., 1999). Each item is rated in a 5- Likert scale in terms of the difficulty the patient has experienced in completing each item. Scores range from 0 to 100, a higher score indicates better recovery. The SIS has adequate to excellent test-rest reliability (Duncan et al., 1999) and excellent criterion validity (Duncan et al., 2002). The assessment will be administered twice during the study trial.

  2. Change from quality of life baseline at 3 months

    Time frame: Initial baseline assessment and 1 week after the 3 months intervention

    The SF-12 is a multipurpose measure of QOL derived from the SF-36 (Ware, Kosinski & Keller, 1996). Two summary measures are produced, the physical component summary (PCS) and mental component summary (MCS) (Turner-Bowker et al., 2003). The 12 items in the SF-12 includes 1 or 2 items from each of the 8 health concepts: physical functioning, role limitations because of physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations because of emotional problems, and mental health (psychological distress and psychological well-being)(Ellis et al., 2013). Finally, because the 8 domains have different ranges, they are transformed to have a common range of 0 (worst health) to 100 (best health).

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

    Time frame: Initial baseline assessment and 1 week after the 3 months intervention

    The Zarit Burden Interview (ZBI) 22-item questionnaire developed by Zarit et al. (1985) has been used extensively in measuring caregiving strain. In addition, shorter versions of the ZBI ranging from 1 to 18 items, have been developed. However, Yu et al. (2019) found that the 6-item version was the most optimal short version as it provided similar diagnostic utility to the original 22-item version with the fewest items. The self-report instrument measures two dimension of caregiving namely personal and role strain using a 5-point scale ranging from 0 'never' to 4 'nearly always' (Herbert, Bravo and Preville, 2000). The scores of each item are added up to form one total score. The maximum score is 88 and higher scores indicate greater burden.

  4. Change from occupational performance baseline at 3 months

    Time frame: Initial baseline assessment and 1 week after the 3 months intervention

    The Canadian Occupational Performance Measure (COPM) based on the Canadian Model of Occupational Performance is designed for use by occupational therapists to detect change in patients' self-perception of their occupational performance over time (Law et al., 1998). With a semi-structured interview, the patient is encouraged to identify problems in self-care, productivity, or leisure activities. It concerns those activities the patient wants, needs, or is expected to do, but cannot do, or those in which the patient is not satisfied with current performance. The patient rates importance of the problems on a 10-point scale from 'not important at all' (score 1) to 'extremely important' (score 10). The patient is also asked to rate satisfaction with performance on a 10-point scale from 'not satisfied at all' to 'extremely satisfied'. These scores range from 0 to 10, higher scores reflect better performance and satisfaction with performance as perceived by the patient.

Other outcomes

  1. Modified Rankin Scale

    Time frame: Initial Baseline Assessment

    The Modified Rankin Scale is used to measure the degree of disability in patients who have had a stroke (Rankin, 1957). The Modified Rankin Scale is an ordered scale coded from 0 (no symptoms at all) through 5 (severe disability) and 6 (death). The conventional method of administration for the MRS is a guided interview process. The assessment is carried out by asking the patient about their activities of daily living, including outdoor activities.

  2. Feasibility Questionnaire

    Time frame: within 1 week after the 3 months intervention

    This questionnaire will consist of a set of questions prepared by researcher to identify the feedbacks of participants regarding the feasibility of the intervention.

  3. Demographic Data

    Time frame: Initial Baseline Assessment

    Participants will fill up a demographic data sheet containing personal and medical information.

  4. 6-item Cognitive Impairment Test

    Time frame: Initial Baseline Assessment

    The Six Item Cognitive Impairment Test (6CIT) is a brief cognitive function test which takes less than five minutes and is widely used in primary care settings. Scores range from 0 to 28, and higher scores indicate significant cognitive impairments.

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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