StrokeNCT04618029
Feasibility of a Home Hazard Management Program for Malaysian Stroke Survivors
A study testing Home Modification and Education in people with Stroke, run by Universiti Putra Malaysia at 3 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Home Modification and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesMalaysia
- Study dates
- 1 Jan 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
Hospital Selayang
Selayang Baru Utara, 68100
Hospital UPM
Serdang, 43400
Hospital Shah Alam
Shah Alam, 40000
About this study
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
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Home Modification, Education
- Keywords
- stroke, fall prevention, environmental modification
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home ModificationOther
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
EducationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 months within the intervention duration
Secondary outcomes (4)
Change from stroke recovery baseline at 3 months
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.
Measured: Initial baseline assessment and 1 week after the 3 months intervention
Change from quality of life baseline at 3 months
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).
Measured: Initial baseline assessment and 1 week after the 3 months intervention
Change from caregiver's burden recovery baseline at 3 months
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.
Measured: Initial baseline assessment and 1 week after the 3 months intervention
Change from occupational performance baseline at 3 months
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.
Measured: Initial baseline assessment and 1 week after the 3 months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jan 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Husna Ahmad Ainuddin, Universiti Putra Malaysia
- Investigators
- Muhammad Hibatullah Romli, PhD, Principal investigator, UPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618029
- Sponsor's protocol ID
- NMRR-20-501-52933
- Status last verified
- May 2022
- First submitted
- 27 Oct 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04618029
- Acronym / sponsor ID
- NMRR-20-501-52933
- Conditions
- Stroke
- Keywords
- stroke, fall prevention, environmental modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A quasi experimental parallel interventional study model in which there will be 2 groups, a treatment group and a controlled group.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Home Modification, Other: Education1. 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. |
| 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home ModificationHome 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 | Other | Treatment Group |
| EducationTechniques 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 | Other | Treatment Group |
Primary outcome
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.
4 secondary outcomes
Change from stroke recovery baseline at 3 months
Time frame: Initial baseline assessment and 1 week after the 3 months intervention
Change from quality of life baseline at 3 months
Time frame: Initial baseline assessment and 1 week after the 3 months intervention
Change from caregiver's burden recovery baseline at 3 months
Time frame: Initial baseline assessment and 1 week after the 3 months intervention
Change from occupational performance baseline at 3 months
Time frame: Initial baseline assessment and 1 week after the 3 months intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Hibatullah Romli, PhD principal investigator
UPM
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Modification and Education in people with Stroke, run by Universiti Putra Malaysia at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from home hazards baseline at 3 months (time frame: Initial baseline assessment and within 1 week after the 3 months intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.