Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001182189
Ethics application status
Approved
Date submitted
25/06/2019
Date registered
20/08/2019
Date last updated
22/11/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effectiveness of Home-Based Therapy on Functional Outcome, Self-Efficacy and Anxiety Among Discharged Stroke Survivors
Scientific title
The Effectiveness of Home-Based Therapy on Functional Outcome, Self-Efficacy and Anxiety Among Discharged Stroke Survivors
Secondary ID [1] 298596 0
None
Universal Trial Number (UTN)
U1111-1235-9552
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
functional performance of stroke survivors 313444 0
anxiety of stroke survivors 313631 0
self efficacy level of stroke survivors 313632 0
Condition category
Condition code
Physical Medicine / Rehabilitation 311879 311879 0 0
Physiotherapy
Stroke 312148 312148 0 0
Haemorrhagic
Stroke 312440 312440 0 0
Ischaemic
Mental Health 312441 312441 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an assessor-blinded randomized control trial involving two types of intervention which are HBT (experimental group) and UT (control group). Stroke survivor will be randomly allocated into HBT (experimental group) and UT (control group). The duration of the intervention is 12 weeks. Participant and their caregiver in HBT group will be given at least one training session with the researcher at Unit Physiotherapy, Cheras Rehabilitation Hospital. Exercise program consist of a total of 7 exercises which include strengthening exercise, task-specific exercise, and balance exercise, with a total duration of 70 minutes. Exercise prescription in HBT group is followed FITT principle. FITT principle is the component of exercise prescription which includes frequency, intensity, time and type (or modality) (Billinger et al. 2014). Participants need to perform an exercise program at home 3 times a week for 12 weeks. A logbook containing exercise’s picture, instruction and intensity will be provided to the participant. Participant or caregiver needs to record the frequency of exercise in the given logbook. The researcher will contact the participant weekly to check on the progress (which will alter the intensity of the exercise), any adverse or unexpected events, and any issue(s) raised by participant or caregiver. Baseline outcome measure data will be assessed pre-intervention and week 13 post-intervention.
caregiver define as the person who is able to provide minimal or moderate assistance to the stroke survivor in daily activities and/ or complex tasks; and able to assist stroke survivor to perform HBT.
Intervention code [1] 314856 0
Rehabilitation
Intervention code [2] 315063 0
Treatment: Other
Comparator / control treatment
the control group in this study is home exercise program or usual therapy (UT) which provided to for stroke survivors upon discharge from physiotherapy outpatient service.
The researcher will be providing consultation on baseline assessment and healthcare advice to participants after evaluated by an assessor.
Participants do not have an exercise program and telephone monitored by the investigator as in the intervention group.

Intervention group (Home-based Therapy) is a transferable exercise prescription prescribed by researcher, which consists of strengthening exercise, walking exercise, task-related exercise and balance exercise. Participant and their caregiver will have at least one training session with the researcher. Participant is required to perform exercise prescription at home with assistance by the caregiver and will be monitored by the researcher via telephone contact.
Control group
Active

Outcomes
Primary outcome [1] 320543 0
measure fall risk with Timed up and Go (TUG) Test
Timepoint [1] 320543 0
Pre-Intervention, 12 weeks Post-intervention
Primary outcome [2] 320544 0
measure mobility status with Timed up and Go (TUG) Test
Timepoint [2] 320544 0
Pre-Intervention, 12 weeks Post-intervention
Primary outcome [3] 320545 0
measure walking speed using Ten-meter walk test (10-mWT)
Timepoint [3] 320545 0
Pre-Intervention, 12 weeks Post-intervention
Secondary outcome [1] 371961 0
measure self-efficacy level using The Stroke Self-Efficacy Questionnaire (SSEQ)
Primary outcome
Timepoint [1] 371961 0
Pre-Intervention, 12 weeks Post-intervention
Secondary outcome [2] 372534 0
screening for anxiety and depression with Hospital Anxiety and Depression Scale
Primary outcome
Timepoint [2] 372534 0
Pre-Intervention, 12 weeks Post-intervention
Secondary outcome [3] 372535 0
measure caregiver strain level with The Modified Caregiver Strain Index
Primary outcome
Timepoint [3] 372535 0
Pre-Intervention, 12 weeks Post-intervention

Eligibility
Key inclusion criteria
Subjects inclusion criteria in this study include:
1. Subject diagnosed with stroke
2. Stroke patient who was discharged from HOPS for more than 4 months.
3. Subject age between 60 to 85
4. Subject requiring caregiver assistance in the activity of daily living (ADL). The caregiver needs to fulfill the caregiver criteria
5. Functional ambulation categories scale > 3. Subject was able to ambulate on level surface without an assistant or only required supervision from one person.

Caregiver inclusion criteria in this study include:
1. Able to read and understand native language newspaper
2. Provide minimal or moderate assistance to the stroke survivor in daily activities, such as transfer, bathing, feeding, dressing, and personal hygiene.
3. Provide moderate or dependent assistance to the stroke survivor in complex tasks, such as shopping, cleaning, driving, cooking, and laundry.
4. Able to assist stroke survivor to perform HBT
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Stroke patient with cognitive impairment (Montreal Cognitive Assessment (MoCA) <26). MoCA score of less than 26 indicates the presence of cognitive impairment.
2. Attended by a home physiotherapist after discharged from HOPS
3. Stroke patient with depression (Hospital Anxiety Depression Scale-Depression HADS-D >11). HADS-D score above 11 indicates that moderate to severe level of depression.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
NIL
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
The sample size of total 72 subjects was obtained by using GPower v3.0.10 for windows with the effect size (f) of 0.14 (large effect), alpha level of p=0.05, power of 0.80, and using the statistical test of ANOVA: repeated measures, within-between interaction

Analysis
1. Adherence rate calculated by [ (Number of practice sessions / Number of planned session) X 100%].
2. Mixed Design Analysis of Variance (ANOVA) will be used to assess the interaction effect, time effect and group effect of mobility level, gait speed, self-efficacy, level of anxiety following intervention in stroke patient who discharges from HOPS.
3. Mixed Design Analysis of Variance (ANOVA) also used to assess the interaction effect, time effect and group effect of caregiver strain level among caregiver in both HBT group and UT group.
4. Intention–to–treat analysis will be carried out to all the data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
1/10/2019
Date of last participant enrolment
Anticipated
29/11/2019
Actual
Date of last data collection
Anticipated
28/02/2020
Actual
Sample size
Target
72
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 21644 0
Malaysia
State/province [1] 21644 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 303139 0
University
Name [1] 303139 0
National University of Malaysia
Country [1] 303139 0
Malaysia
Primary sponsor type
University
Name
National University of Malaysia
Address
National University of Malaysia
Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 303136 0
None
Name [1] 303136 0
Address [1] 303136 0
Country [1] 303136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303687 0
Medical Research Ethics Committee(MREC)/MOH Research Grants (MRG) / Publication
Ethics committee address [1] 303687 0
Medical Research Ethics Committee(MREC)/MOH Research Grants (MRG) / Publication
NIH Secretariat
Ministry of Health Malaysia,
c/o Institute for Health Management,
Block A, Kompleks Institut Kesihatan Negara (NIH)
No 1 Jalan Setia Murni U13/52,
Seksyen U13 Bandar Setia Alam,
40170 Shah Alam
Ethics committee country [1] 303687 0
Malaysia
Date submitted for ethics approval [1] 303687 0
01/05/2019
Approval date [1] 303687 0
06/08/2019
Ethics approval number [1] 303687 0
NMRR ID: NMRR–19–941–46993
Ethics committee name [2] 303688 0
Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia
Ethics committee address [2] 303688 0
Sekretariat Etika Penyelidikan Universiti Kebangsaan Malaysia,
Tingkat 1, Blok Klinikal, Hospital Canselor Tuanku Muhriz, Pusat Perubatan UKM,
Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur
Ethics committee country [2] 303688 0
Malaysia
Date submitted for ethics approval [2] 303688 0
29/04/2019
Approval date [2] 303688 0
09/10/2019
Ethics approval number [2] 303688 0
JEPUKM – JEP-2019-448

Summary
Brief summary
This is an assessor-blinded randomized control trial involving two types of intervention which are home-based therapy (experimental group) and usual therapy (control group). The purpose of this study is to identify the feasibility and effectiveness of home-based therapy (HBT) in stroke survivors after discharge from hospital physiotherapy outpatient service based on self-efficacy, anxiety and functional outcome (mobility and gait speed). This study can hypothesize that the HBT yields better effects than UT on mobility level, gait speed, self-efficacy and level of anxiety among stroke patients who have been discharged from hospital outpatient physiotherapy service.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94494 0
Mrs Chong Pui Kei
Address 94494 0
Program Physiotherapy Faculty of Allied Health Sciences, National University of Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur
Country 94494 0
Malaysia
Phone 94494 0
+60169604100
Fax 94494 0
Email 94494 0
[email protected]
Contact person for public queries
Name 94495 0
Mrs Chong Pui Kei
Address 94495 0
Program Physiotherapy Faculty of Allied Health Sciences, National University of Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur
Country 94495 0
Malaysia
Phone 94495 0
+60169604100
Fax 94495 0
Email 94495 0
[email protected]
Contact person for scientific queries
Name 94496 0
Mrs Chong Pui Kei
Address 94496 0
Program Physiotherapy Faculty of Allied Health Sciences, National University of Malaysia Jalan Raja Muda Abdul Aziz 50300 Kuala Lumpur
Country 94496 0
Malaysia
Phone 94496 0
+60169604100
Fax 94496 0
Email 94496 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
demographic data, study outcomes
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
email:[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2515Clinical study report  [email protected]



Results publications and other study-related documents

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Current Study Results
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Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4130Plain language summaryNo In summary, there was high adherence rate to the h... [More Details]

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