ATTEND-Family-led Rehabilitation After Stroke in India (ATTEND)

April 24, 2014 updated by: jeyarajpandian, Christian Medical College and Hospital, Ludhiana, India

Family-led Rehabilitation After Stroke in India

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Punjab
      • Ludhiana, Punjab, India, 141008
        • Christian Medical College and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control arm
Routine hospital based physiotherapy
Other: Control arm
Routine hospital based physiotherapy
Other: Physiotherapy intervention arm
Caregiver delivered, home based physiotherapy
Other: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in modified Rankin Score
Time Frame: 3rd and 6th month
3rd and 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christian Medical College and Hospital, Ludhiana, India

Collaborators

The George Institute for Global Health, Australia

Investigators

  • Principal Investigator: Jeyaraj D Pandian, MD DM FRACP, Christian Medical College and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Cancer Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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