Back to resultsATTEND-Family-led Rehabilitation After Stroke in India (ATTEND)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Physiotherapy
Control arm
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Adults (>18 years)
- Recent (<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke
- Residual disability (requiring help from another person for everyday activities)
- Expected to survive to discharge from hospital with a reasonable expectation of six month survival
- Able (or by proxy) to provide informed consent
Exclusion Criteria:
- Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care
- Those unwilling/unable to adhere to follow up.
Sites / Locations
- Christian Medical College and Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Control arm
Physiotherapy intervention arm
Arm Description
Routine hospital based physiotherapy
Caregiver delivered, home based physiotherapy
Outcomes
Primary Outcome Measures
Change in modified Rankin Score
Secondary Outcome Measures
Full Information
NCT ID
NCT02123875
First Posted
April 11, 2014
Last Updated
April 24, 2014
Sponsor
Christian Medical College and Hospital, Ludhiana, India
Collaborators
The George Institute for Global Health, Australia
1. Study Identification
Unique Protocol Identification Number
NCT02123875
Brief Title
ATTEND-Family-led Rehabilitation After Stroke in India
Acronym
ATTEND
Official Title
Family-led Rehabilitation After Stroke in India
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Christian Medical College and Hospital, Ludhiana, India
Collaborators
The George Institute for Global Health, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
ATTEND Trial is based on early supported discharge- home based stroke rehabilitation model which proves to offer several advantages in low and mid income countries. The objectives of the pilot stude were to determine that with a randomized blinded outcome assessor, controlled trial, family- led caregiver- delivered home based rehabilitation is better than usual care for those with disabling stroke in India and the feasibility of this model.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
Other
Arm Description
Routine hospital based physiotherapy
Arm Title
Physiotherapy intervention arm
Arm Type
Other
Arm Description
Caregiver delivered, home based physiotherapy
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Type
Other
Intervention Name(s)
Control arm
Intervention Description
Routine hospital based physiotherapy
Primary Outcome Measure Information:
Title
Change in modified Rankin Score
Time Frame
3rd and 6th month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults (>18 years)
Recent (<1 month) acute ischaemic/haemorrhagic/ undifferentiated stroke
Residual disability (requiring help from another person for everyday activities)
Expected to survive to discharge from hospital with a reasonable expectation of six month survival
Able (or by proxy) to provide informed consent
Exclusion Criteria:
Unable to identify a suitable family - nominated caregiver for training and subsequent delivery of care
Those unwilling/unable to adhere to follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeyaraj D Pandian, MD DM FRACP
Organizational Affiliation
Christian Medical College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christian Medical College and Hospital
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813082
Citation
Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.
Results Reference
derived
PubMed Identifier
32640944
Citation
Wang X, Moullaali TJ, Li Q, Berge E, Robinson TG, Lindley R, Zheng D, Delcourt C, Arima H, Song L, Chen X, Yang J, Chalmers J, Anderson CS, Sandset EC. Utility-Weighted Modified Rankin Scale Scores for the Assessment of Stroke Outcome: Pooled Analysis of 20 000+ Patients. Stroke. 2020 Aug;51(8):2411-2417. doi: 10.1161/STROKEAHA.119.028523. Epub 2020 Jul 9.
Results Reference
derived
Learn more about this trial
ATTEND-Family-led Rehabilitation After Stroke in India
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