Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04618029|
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : September 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Home Modification Other: Education||Not Applicable|
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 40 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A quasi experimental parallel interventional study model in which there will be 2 groups, a treatment group and a controlled group.|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Actual Study Start Date :||January 1, 2021|
|Estimated Primary Completion Date :||December 1, 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Treatment Group
Other: Home Modification
Home Modification Intervention
Provide recommendations to:
Provide recommendations to:
Provide recommendations to:
Provide recommendations to:
• Fix an adhesive tape for stair contrast
Techniques Description Energy Conservation
No Intervention: 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- Demographic Data [ Time Frame: Initial Baseline Assessment ]Participants will fill up a demographic data sheet containing personal and medical information.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04618029
|Contact: Husna Ahmad Ainuddin, MMedScemail@example.com|
|Selayang Baru Utara, Malaysia, 68100|
|Contact: Dr. Tengku Intan Norleen Bt Tengku Sharif|
|Serdang, Malaysia, 43400|
|Contact: Dr. Mazatulfazura SF Salim|
|Hospital Shah Alam||Recruiting|
|Shah Alam, Malaysia, 40000|
|Contact: Dr. Ruzita Binti Othman|
|Principal Investigator:||Muhammad Hibatullah Romli, PhD||UPM|