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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Change from home hazards baseline at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
- Different hospitals for the treatment and control group
- Two independent assessor will be recruited for data collection and data analysis of outcomes
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Treatment Group
- 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)
- 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.
干预措施: Home Modification (Other)
Treatment Group
- 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)
- 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.
干预措施: Education (Other)
Controlled Group
- 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.
结局指标
主要结局
Change from home hazards baseline at 3 months
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Husna Ahmad Ainuddin
Principal Investigator and Doctoral Student, Department of Rehabilitation, Faculty of Medicine and Health Sciences
Universiti Putra Malaysia