Stroke Clinical Trial
— SPORTOfficial title:
A Randomized Controlled Trial to Improve the Uptake of and Adherence to Outpatient Rehabilitation Services Among Stroke Patients
Verified date | August 2019 |
Source | National University, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Stroke is the leading cause of long-term disability in Singapore, and studies
have found that intensive specialized stroke rehabilitation can improve post-stroke
functional outcomes for a substantial proportion of stroke patients. However, despite the
benefits associated with adherence to prescribed rehabilitation, the uptake rate of
outpatient rehabilitation services (ORS) in Singapore is only 33%.
According to local longitudinal studies, the financial burden of out-of-pocket service costs
and the inconvenient transportation from home to rehabilitation centres are important
barriers to access to ORS.
Objective: To examine the effect and cost-effectiveness of providing incentives for ORS to
improve the uptake of ORS compared to usual care (control) with no incentives
Hypothesis: An evidence-based program to test the effectiveness of providing incentives to
alleviate the financial burden as well as inconvenience of transportation for ORS will
improve the uptake of and adherence to ORS among stroke patients.
Methodology: This study is an individual-based randomized controlled trial (RCT) of 300
stroke patients recruited from Singapore General Hospital (SGH) and Changi General Hospital
(CGH). They will be randomized to one of three study arms (education only, free
transportation, and free services and transportation) and interviewed at the time of
recruitment and four months after the enrolment in the study. Participants' health
conditions, socioeconomic situation, health & medical services utilization, stroke-related
disability measures, quality of life, and reasons for uptake/rejection/withdraw from the
services will be collected during both baseline and the 4th month assessments.
Significance: As the first study in Singapore to test innovative ways to increase the stroke
ORS uptake rates, it will provide evidence for future policy changes in financing outpatient
rehabilitation and other long-term care services in Singapore. It will also provide important
empirical parameter estimates for Systems Dynamics modelling of the demand and supply of ORS
in Singapore.
Status | Completed |
Enrollment | 266 |
Est. completion date | November 30, 2019 |
Est. primary completion date | November 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with stroke as defined by the World Health Organization's criteria; - Discharged to home; - Recommended by physicians to continue outpatient rehabilitation afte discharge; - Singapore citizen or Permanent Resident; and - Provision of informed consent. Exclusion Criteria: - Stroke patients who are suffering from severe dysphasia without caregiver or proxy; - Cognitively impaired patients without caregiver or proxy; and - Age < 20 years. |
Country | Name | City | State |
---|---|---|---|
Singapore | Changi General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University, Singapore | Changi General Hospital, Duke-NUS Graduate Medical School, Ministry of Health, Singapore, Singapore General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Uptake rate of incentivised rehabilitation services | Uptake rate of incentivised services will be measured by number of participants who attend at least one rehabilitation session. | 3 months post-discharge | |
Secondary | Adherence rate of incentivised rehabilitation services | Adherence rate will be measured by the proportion of recommended sessions participants attended versus number of sessions recommended. | 3 months post-discharge | |
Secondary | Barriers for outpatient rehabilitation services (ORS) utilization | ORS take-up rate between Group 2 and Group 3 will be computed to assess if transportation or out of pocket costs are barriers for ORS. | 3 months post discharge | |
Secondary | Effectiveness of interventions on participants' health outcomes | The investigators will be using Modified Barthel Index to measure health outcomes, comparing the changes from baseline to assessment at 4th month. | Change from Baseline MBI at 4 months | |
Secondary | Cost effectiveness of incentivised ORS | The investigators will be using the cost data collected from rehabilitation centres and actual costs for the incentivised ORS to assess cost effectiveness. Incremental cost-effectiveness ratio (ICER) will be computed using the extra cost with incentives ($) / Improved uptake rate of rehabilitation with incentives (% attending at least one session). | 3 months post-discharge |
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