NCT02247921

Brief Summary

Stroke is the second leading cause of mortality and disability among adults worldwide. Rehabilitation is an effective treatment for stroke; however rehabilitation services are far from adequate in China, especially in rural areas where the health and economic burden of disability from stroke is very high. The investigators propose to develop, implement, and evaluate an evidence-based caregiver-delivered stroke rehabilitation program designed to improve the physical functioning of disabled stroke patients in rural China.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Aug 2014

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

2.4 years

First QC Date

September 13, 2014

Last Update Submit

May 2, 2018

Conditions

Stroke

Keywords

caregiver delivered rehabilitationnurse-organized servicedisabled stroke patients

Outcome Measures

Primary Outcomes (1)

  • Barthel Index (activities of daily living) at 6 months

    6 months

Secondary Outcomes (5)

  • Barthel Index at 3 months

    3 months

  • Functional Ambulation Classification (FAC) at 6 months

    6 months

  • EQ-5D quality of life at 6 months

    6 months

  • Patient Health Questionnaire - 9 items at 6 months

    6 months

  • Modified Rankin Scale at 3 and 6 months

    3 and 6 months

Other Outcomes (3)

  • Caregiver Burden Index at 6 months

    6 months

  • hospitalization

    6 months

  • medical costs

    6 months

Study Arms (2)

Rehabilitation

EXPERIMENTAL

nurse-led caregiver-delivered rehabilitation

Other: Rehabilitation

Usual care

NO INTERVENTION

The patients in the control arm will receive conventional care in terms of access to rehabilitation in hospital, timeliness of discharge and follow-up, without any explicit provision of caregiver training or accelerated discharge.

Interventions

RehabilitationOTHER

Patients recruited into the intervention arm will have their family-nominated caregivers trained by a trained nurse and guided by a culturally appropriate and easy-to-understand rehabilitation manual to be given to caregivers at the last session, shortly before hospital discharge to reduce contamination. The training sessions will take at least 90 minutes per day for 2 or 3 days.The nurse will call the patients and caregivers at 2, 4, and 8 weeks after hospital discharge to monitor progress and offer guidance on rehabilitation.Duration of the standardized yet individualized intervention by nurses will be 8 weeks; however, trained caregivers are expected to deliver the rehabilitation services to patients as long as they are needed.

Rehabilitation

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (≥18 years，and≤79 years);
  • Recent (\<1 month) first-ever acute ischemic/hemorrhagic/undifferentiated stroke patients;or recurrent patients with the result of Modified Rankin Scale (MRS) no more than 2 points.
  • With a reasonable expectation of 6 month survival post-discharge (i.e. not palliative, no evidence of widespread cancer etc.);
  • Residual disability (requiring physical assistance for core activities of daily living defined as a Barthel Index score of 80 or lower)

You may not qualify if:

  • Unable to identify a suitable family-nominated caregiver for training and subsequent delivery of care
  • Unable to provide informed consent from both the patient (or by proxy) and the caregiver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Georgeinstitute of Global Health at Peking University Health Science Center

Beijing, Beijing Municipality, 100088, China

Location

Related Publications (1)

  • Zhou B, Zhang J, Zhao Y, Li X, Anderson CS, Xie B, Wang N, Zhang Y, Tang X, Prvu Bettger J, Chen S, Gu W, Luo R, Zhao Q, Li X, Sun Z, Lindley RI, Lamb SE, Wu Y, Shi J, Yan LL. Caregiver-Delivered Stroke Rehabilitation in Rural China. Stroke. 2019 Jul;50(7):1825-1830. doi: 10.1161/STROKEAHA.118.021558. Epub 2019 Jun 10.

    PMID: 31177978DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Lijing Yan

    Duke Kunshan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2014

First Posted

September 25, 2014

Study Start

August 1, 2014

Primary Completion

December 31, 2016

Study Completion

July 31, 2017

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CN(1)