Clinical trial NCT04618029: Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
fall prevention
environmental modification
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi experimental parallel interventional study model in which there will be 2 groups, a treatment group and a controlled group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from home hazards baseline at 3 months
timeFrame: Initial baseline assessment and within 1 week after the 3 months intervention
measure: Change from falls efficacy baseline at 3 months
timeFrame: Initial baseline assessment and within 1 week after the 3 months intervention
measure: Falls Diary
timeFrame: 3 months within the intervention duration
Secondary outcomes:
measure: Change from stroke recovery baseline at 3 months
timeFrame: Initial baseline assessment and 1 week after the 3 months intervention
measure: Change from quality of life baseline at 3 months
timeFrame: Initial baseline assessment and 1 week after the 3 months intervention
measure: Change from caregiver's burden recovery baseline at 3 months
timeFrame: Initial baseline assessment and 1 week after the 3 months intervention
measure: Change from occupational performance baseline at 3 months
timeFrame: Initial baseline assessment and 1 week after the 3 months intervention
Other outcomes:
measure: Modified Rankin Scale
timeFrame: Initial Baseline Assessment
measure: Feasibility Questionnaire
timeFrame: within 1 week after the 3 months intervention
measure: Demographic Data
timeFrame: Initial Baseline Assessment
measure: 6-item Cognitive Impairment Test
timeFrame: Initial Baseline Assessment
Locations:
city: Selayang Baru Utara
country: Malaysia
facility: Hospital Selayang
city: Serdang
country: Malaysia
facility: Hospital UPM
city: Shah Alam
country: Malaysia
facility: Hospital Shah Alam
Study officials:
affiliation: UPM
name: Muhammad Hibatullah Romli, PhD
role: PRINCIPAL_INVESTIGATOR
References: