Stroke Patients' Outpatient Rehabilitation Therapy (SPORT)

NCT03165630 | Completed

• 1 other identifier: NMRC/HSRG/0059/2016
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Incentives; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Adherence rate of incentivised rehabilitation services

  3 months post-discharge

• Barriers for outpatient rehabilitation services (ORS) utilization

  3 months post discharge

• Effectiveness of interventions on participants' health outcomes

  Change from Baseline MBI at 4 months

• Cost effectiveness of incentivised ORS

  3 months post-discharge

Study Arms (3)

Group 1

NO INTERVENTION

Education or Control group.

Group 2

EXPERIMENTAL

Transportation incentives

Behavioral: Transportation incentives

Group 3

EXPERIMENTAL

Transportation and rehabilitation services incentives

Behavioral: Transportation and rehabilitation services incentives

Interventions

Transportation incentives BEHAVIORAL

Free transportation only for the first 3 months post-discharge.

Group 2

Transportation and rehabilitation services incentives BEHAVIORAL

Free transportation and rehabilitation services 3 months post-discharge.

Group 3

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Stroke patients who are suffering from severe dysphasia without caregiver or proxy;
• Cognitively impaired patients without caregiver or proxy; and
• Age \< 20 years.

Sponsors & Collaborators

• National University of Singapore: lead
• Ministry of Health, Singapore: collaborator
• Duke-NUS Graduate Medical School: collaborator
• Changi General Hospital: collaborator
• Singapore General Hospital: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Stroke

Interventions

Transportation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture

Study Officials

• David B Matchar, MD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

• Sherry Young, MD

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

• Deidre A De Silva, MD

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The 4th month assessor is unaware of the arm participants are assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Health Services & Systems Research, Duke-NUS Medical School

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 24, 2017
• Study Start: May 26, 2017
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: February 26, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)