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Trial registered on ANZCTR


Registration number
ACTRN12616001195448
Ethics application status
Approved
Date submitted
24/08/2016
Date registered
30/08/2016
Date last updated
24/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Piloting the “Stepping On after Stroke” falls prevention program for community stroke survivors in Singapore: A feasibility study
Scientific title
Piloting the “Stepping On after Stroke” falls prevention program for community stroke survivors in Singapore: A feasibility study
Secondary ID [1] 290011 0
None
Universal Trial Number (UTN)
U1111-1186-8437
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 300025 0
Falls 300026 0
Condition category
Condition code
Stroke 299917 299917 0 0
Ischaemic
Stroke 299919 299919 0 0
Haemorrhagic
Injuries and Accidents 299920 299920 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study period:
November 2016 – July 2017
* Subject recruitment will start only when IRB approves.
* Intervention will be from November 2016 to January 2017.
* Follow up period will be from January 2017 to July 2017.

Clinic sites for conducting this study:
1. Wellness Center, Alexandra Health System (Singapore)
2. SPD Day Rehabilitation Center (Singapore)

Stepping On leader training workshop
This is a 1.5-day face-to-face group-based training workshop conducted by master trainer Mr Xu Tianma (Principal Investigator)(PI) for allied health professionals in Singapore to become qualified Stepping On program leaders. It provides them with the basic knowledge of Stepping on program in preparation for setting up the group based Stepping On programs for community older adults. The participant will learn the key elements of the program and basic skills in facilitating the groups by participating in role play sessions during the workshop in a classroom setting. Ankle weights will be used to demonstrate the upgrading of exercises during the role play sessions.

Stepping On after Stroke leader training workshop
This is an add-on training workshop to any Stepping On leaders who have completed the 1.5 days Stepping On leader training. It will be a face-to-face group-based training by master trainer Xu. Additional components to Stepping On program will be shared at the half day workshop. Role play will be conducted by trainees and facilitated by the master trainer. No other physical equipment will be needed except ankle weights for muscle strengthening exercises during the workshop.

About master trainer
The Stepping On leader training workshops are facilitated by Mr Xu Tianma who is the PI for this research project. Mr Xu is an occupational therapist (OT) with more than 15 years of clinical experience working with older adults and stroke population. He teaches the OT degree program in Singapore Institute of Technology. He has conducted many training sessions to healthcare professionals in the areas of falls prevention, and stroke rehabilitation. He has successfully conducted two Stepping On Leader Training Workshops in March and April 2016. Mr Xu is currently pursuing his PhD study with University of Sydney under Professor Lindy Clemson, the main author of Stepping On program.

Staff involved:
Stepping On after Stroke program leaders
At least one OT and/or one physiotherapist(PT) from the participating rehabilitation center who have successfully completed the Stepping On facilitator training will be invited to join the half-day Stepping on after Stroke program leader training workshop. They will become Stepping On after Stroke program leaders in facilitating the program during the study.

Onsite clinical coordinators
There will be at least one therapist from each participating center to be appointed as onsite clinical coordinator to coordinate the participant recruitment and weekly sessions.

Invited guest speakers
External eye specialist and pharmacist will be invited as guest speakers to give a short session to stroke participants on common eye conditions in people after stroke in week 5 and medications and falls after stroke in week 6 respectively. The estimated time allocated for each expert will be 30 - 45 minutes.

Program outline
Pre-intervention evaluation will be conducted by the trained assessors at baseline using the series of standardized outcome measures. Each assessment session will last about one hour for each participant.

7 weeks intervention
-Weekly session will be scheduled on weekdays at a comfortable time slot that suits the participants and the center.
-Each group session will be run in an enclosed environment.
-There will be one 2-hourly group session facilitated by a qualified Stepping On after Stroke program leader in each week for 7 weeks.
-Each session consists of 20-30 minutes balance and strengthening exercises led by physiotherapist and facilitator.
-Domestic helpers or caregivers are encouraged to join the weekly session with the stroke participants.
-Each participant will receive one additional supervised community mobility practice session in a smaller group on top of the big group outing in week 5.
-Each participant will be provided with weekly program handouts and a communication booklet and weekly homework sheet at each session.
-The homework sheet will include Balance exercises & Strengthening exercises that each participant needs to tick daily once completed.

Two additional educational sessions will be conducted for family members and domestic helpers in the 1st and 7th week. Each educational session will last for 2 hours. OT will share the program overview, nature of stroke, community resources, common falls prevention strategies with all family members and helpers. OT will discuss with all participants about their supporting role in preventing their loved ones from falling in the community.

Follow-up home visit
OT will contact each participant to arrange for home visit 4-6 weeks after the 7th session. It aims to follow through of preventive strategies and assist with home modifications. Phone call will be a back-up option if home visit is not possible. All participants and program leaders will be invited to fill up the program evaluation survey form after the home visit.

Post-intervention reevaluation
-Same outcome measures will be conducted after the home visit.
-All participants and program leaders will be invited to fill up the program evaluation survey form after the home visit.

3-month booster session
-All participants will be invited to join the 2-hour booster group session at 3 months after 7th session.
-Facilitator and PT will review and conduct group exercise for 20 minutes.
-During the session, every stroke participant and family members or helper will share with each other how they benefited from the program, such as their self-coping and falls prevention strategies, as well as challenges faced since the completion of the 7 weeks program.
-Program evaluation survey will be issued to all participants again for their feedback after the booster session.

6-month follow-up
-All stroke participants will be followed up for a period of 6 months after 7th session.
-Each participant will be asked to keep track of their fall incidents (if any) during the 7 weeks program and 6 months after the 7th session.
-Each participant will be asked to fill up the monthly fall calendar provided by the researcher and submit it to the onsite clinical coordinator or the researcher at the beginning of the following month. Family members and helpers will be encouraged to assist the stroke participant in this activity. Researchers will remind them by phone call if the monthly fall calendar is not returned on time.

Fidelity check
The PI Xu will conduct the fidelity check in week 3-5 to ensure the interventions are carried out as planned. Feedback will be given to the program leaders in each center after each fidelity check.
Intervention code [1] 295721 0
Prevention
Intervention code [2] 295723 0
Rehabilitation
Intervention code [3] 295724 0
Behaviour
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299403 0
To assess the feasibility of implementing the evidence-based Australian "Stepping On" program, a group-based program that aims to reduce fall rate and increase community participation for community stroke survivors in Singapore.

This outcome will be assessed through the data findings from specifically designed program evaluation survey (see the attached program evaluation survey forms) from all participants and program leaders, recruitment process, number of eligible subjects who declined to take part in the study, weekly attendance rate, fidelity check by master trainer in week 3-5, and field notes from the program leaders will be used to evaluate the feasibility of implementing this program.
Timepoint [1] 299403 0
end of the 6 months post-intervention follow-up
Primary outcome [2] 299404 0
To assess the applicability and effectiveness of such a program by examining important social and cultural parameters that are needed to design a larger-scale study, such as willingness of participants to join the group based sessions, number of eligible participants in the community settings, compliance rates, follow-up rates, response rates to fall calendar and characteristics of the proposed outcome measures.

This outcome will be assessed through the monthly fall calendar, weekly attendance, weekly homework sheet, pre-post clinical outcome measures, and specifically designed program evaluation survey.

The selected clinical outcome measures are listed as following:
Questionnaires for Stroke participants
- Falls Efficacy Scale (International) (FES-I)
- Falls Behavioural (FaB) Scale
- Life space assessment
- Modified Reintegration to Normal Living Index (mRNLI)

Evaluation tools used by the therapist
- Short physical performance battery (SPPB)
- Goal Attainment Scale (GAS)

Questionnaires for caregivers
- Modified Caregiver Strain Index
- SF-12 Health Survey
Timepoint [2] 299404 0
end of the 6 months post-intervention follow-up
Primary outcome [3] 299405 0
To investigate the effectiveness of additional educational sessions on stroke and falls prevention in empowering and increasing the coping strategies of caregivers through the learned knowledge, handling skills and community resources.

This outcome will be assessed through the specifically designed program survey forms, the pre-post outcome measures for family members and domestic helpers, such as SF-12 Health Survey forms and Modified Caregiver Strain Index.
Timepoint [3] 299405 0
end of the booster session (3 months after the 7th session)
Secondary outcome [1] 327086 0
Changes in safety behaviors

This outcome will be assessed through the pre-post Falls Behavioral Scale.
Timepoint [1] 327086 0
End of the follow-up home visit (4-6 weeks after the 7th session)
Secondary outcome [2] 327127 0
Fall rate

This will be assessed through the monthly fall calendar.
Timepoint [2] 327127 0
end of the 6 months post-intervention follow-up
Secondary outcome [3] 327128 0
Characteristic of falls, such as fall pattern, location of fall

This will be assessed through the monthly fall calendar.
Timepoint [3] 327128 0
end of the 6 months post-intervention follow-up

Eligibility
Key inclusion criteria
Inclusion criteria for stroke participant:
* Age 50 and above
* Diagnosed with stroke (first or recurrent stroke) within two years
* Medically stable
* Able to walk minimum 10 meters unsupported with or without aid
* Has concerns about falling or had a history of fall
* Able to communicate verbally in conversational English or Mandarin
* Cognitively intact (Abbreviated Mental Test: 8 and above)
* Able to make decision and give consent
* Stays with a caregiver (either family member or domestic helper)

Inclusion criteria for family member and domestic helper
* Family member and domestic helper of the enrolled stroke participant
* Able to understand and speak conversational English or Mandarin
* Give consent
* The age limit for family members and domestic helpers will be 18 and above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for stroke participants:
* Unable to express verbally or understand verbal instructions
* Cognitively impaired (AMT<8)
* Wheelchair bound or bed bound
* Medically unstable, e.g. unstable angina, untreated fits.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Justification of sample size
Conducting 2 groups of Stepping On after Stroke program will be sufficient to test its workability and feasibility in the community rehabilitation settings in Singapore. The recommended number of elderly participants in each group for the original Stepping On program is 12. However, due to the complexity and disability of people with stroke, literature suggest that the appropriate number of stroke participants in each group is 6-8, which was further confirmed by local therapists and experts in the previous studies. Hence, we will include up to 8 stroke participants in each group. Together with their family members and domestic helpers, the total number of participants in this study will be up to 48 (see below breakdown).
Group 1:
Stroke participants: 8
Family members: 8
Domestic helpers: 8

Group 2:
Stroke participants: 8
Family members: 8
Domestic helpers: 8

Data analysis and interpretation
Pre-post evaluation
All assessors will be trained in using the following outcome measures by the researchers during the half-day Stepping On after Stroke program leader training workshop. The data collected from the pre-post outcome measures will be used for analysis.
The data collected from the pre-post outcome measures will be used to determine if the selected outcome measures are culturally relevant and applicable to detect any improvements or changes in balance, behaviour, safety strategies and community participation. Analysis will be using graphs and descriptive statistics to visualize any trends. The acceptance and usefulness of the measures will be determined.

Program evaluation survey
The specially designed Program evaluation survey forms for stroke participant and caregivers will be translated into Chinese with back translation method. All stroke participants, family members, domestic helpers, and program leaders will be invited to fill up the program evaluation survey form after the post-intervention home visit and 3-month booster session. General feedbacks on the program structure, outline, content, cultural relevancy, duration, timing, quality of program leaders, program location and challenges will be collected and analyzed.

Monthly fall calendar
All stroke participants will be asked to fill up the monthly fall calendar in bilingual languages (English and Chinese) throughout the 8 months study period. Each participant will submit their monthly fall calendar to the researcher or onsite clinical coordinator in the respective day rehabilitation center at the beginning of the following month. In the event of fall, the participant is asked to call the onsite clinical coordinator or the researcher. Details of the fall incidents (if any) including a number of falls, fall patterns, location and time of falls will be obtained and analyzed to calculate the fall rate and identify the common fall risk factors among the participants. The compliance rate, data accuracy, challenges faced and format of the monthly calendar will be analyzed for further improvement.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
12/09/2016
Actual
3/11/2016
Date of last participant enrolment
Anticipated
12/10/2016
Actual
1/12/2016
Date of last data collection
Anticipated
31/05/2017
Actual
3/07/2017
Sample size
Target
48
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 8122 0
Singapore
State/province [1] 8122 0

Funding & Sponsors
Funding source category [1] 294380 0
Charities/Societies/Foundations
Name [1] 294380 0
Singapore Association of Occupational Therapists
Country [1] 294380 0
Singapore
Primary sponsor type
Individual
Name
Xu Tianma
Address
Postgrad Student Office, level 3, M Block
Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country
Australia
Secondary sponsor category [1] 293223 0
Individual
Name [1] 293223 0
Lindy Clemson
Address [1] 293223 0
C43M - M Block
Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country [1] 293223 0
Australia
Secondary sponsor category [2] 293224 0
Individual
Name [2] 293224 0
Koh Choon Huat Gerald
Address [2] 293224 0
Saw Swee Hock School of Public Health,
National University of Singapore
#10-03-G, Tahir Foundation Building, Block MD1, 12 Science Drive 2,
Singapore 117549
Country [2] 293224 0
Singapore
Secondary sponsor category [3] 293225 0
Individual
Name [3] 293225 0
Natasha Lannin
Address [3] 293225 0
Department of Community and Clinical Allied Health
La Trobe Clinical School, Alfred Centre,
level 4. Burnet Tower: 89 Commercial Road, Melbourne VIC 3004
Country [3] 293225 0
Australia
Secondary sponsor category [4] 293228 0
Individual
Name [4] 293228 0
Catherine Dean
Address [4] 293228 0
The Faculty of Medicine and Health Sciences
Building F10A, Ground Floor 2 Technology Place
Macquarie University NSW 2109
Australia
Country [4] 293228 0
Australia
Secondary sponsor category [5] 293229 0
Individual
Name [5] 293229 0
Kate O’Loughlin
Address [5] 293229 0
M Block
Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country [5] 293229 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295804 0
National University of Singapore Institutional Review Board
Ethics committee address [1] 295804 0
Ethics committee country [1] 295804 0
Singapore
Date submitted for ethics approval [1] 295804 0
14/08/2016
Approval date [1] 295804 0
25/10/2016
Ethics approval number [1] 295804 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1059 1059 0 0
/AnzctrAttachments/371368-PIS and CF_XU (Stroke participant_V1).pdf (Participant information/consent)
Attachments [2] 1060 1060 0 0
/AnzctrAttachments/371368-PIS and CF_XU (Caregiver_V1).pdf (Participant information/consent)
Attachments [3] 1061 1061 0 0
/AnzctrAttachments/371368-Appendix A_program outline.docx (Other)
Attachments [4] 1062 1062 0 0
/AnzctrAttachments/371368-Appendix C_Data collection sheet.docx (Other)
Attachments [5] 1063 1063 0 0
/AnzctrAttachments/371368-Appendix L_fall calendar (Oct).docx (Other)
Attachments [6] 1064 1064 0 0
/AnzctrAttachments/371368-Recruitment flyer (stroke participants).pdf (Other)
Attachments [7] 1065 1065 0 0
/AnzctrAttachments/371368(v24-08-2016-19-37-16)-Study protocol (v8).pdf (Protocol)
Attachments [8] 1070 1070 0 0
/AnzctrAttachments/371368-Appendix O - program evaluation (therapist).pdf (Other)
Attachments [9] 1071 1071 0 0
/AnzctrAttachments/371368-Appendix N - program evaluation (caregiver).pdf (Other)
Attachments [10] 1072 1072 0 0
/AnzctrAttachments/371368-Appendix M_program evaluation (stroke participant).pdf (Other)

Contacts
Principal investigator
Name 68530 0
Mr Xu Tianma
Address 68530 0
M Block Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country 68530 0
Australia
Phone 68530 0
+65 65928673
Fax 68530 0
Email 68530 0
tixu4146@uni.sydney.edu.au
Contact person for public queries
Name 68531 0
Xu Tianma
Address 68531 0
M Block Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country 68531 0
Australia
Phone 68531 0
+65 65928673
Fax 68531 0
Email 68531 0
tixu4146@uni.sydney.edu.au
Contact person for scientific queries
Name 68532 0
Lindy Clemson
Address 68532 0
C43M, M Block Cumberland Campus
The University of Sydney
75 East St Lidcombe NSW 2141. AUSTRALIA
Country 68532 0
Australia
Phone 68532 0
+612935 19372
Fax 68532 0
Email 68532 0
lindy.clemson@sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFalls amongst older people in Southeast Asia: a scoping review.2017https://dx.doi.org/10.1016/j.puhe.2016.12.035
N.B. These documents automatically identified may not have been verified by the study sponsor.