http://onlinelibrary.wiley.com/doi/10.1111/ijs.12475/abstract;jsessionid=83A9CC168723235DE87F1FA4A6AAEF3F.f02t02?
Article first published online: 9 MAR 2015
DOI: 10.1111/ijs.12475
© 2015 World Stroke Organization
Issue
International Journal of Stroke
Additional Information(Show All)
- Conflict of interest: None declared.
- Funding: Australian NHMRC program (571281) and project (1045391) grants and The George Institute for Global Health, University of Sydney, Australia.
- Unique identifier: NCTO2123875.
- Clinical trial registration URL: http://www.clinicaltrials.gov.
Keywords:
- caregiver;
- developing countries;
- early supported discharge;
- home-based care;
- quality of life;
- rehabilitation;
- stroke;
- therapy
Background
The
aim of this pilot study was to determine the feasibility of a
multicenter, randomized, controlled trial in India of a family-led,
trained caregiver-delivered, home-based rehabilitation intervention vs.
routine care.
Methods
A
prospective, randomized (within seven-days of hospital admission),
blinded outcome assessor, controlled trial of structured home-based
rehabilitation delivered by trained and protocol-guided family
caregivers (intervention) vs. routine care alone (control) was conducted
in patients with residual disability. Key feasibility measures were
recruitment, acceptance and adherence to assessment procedures, and
follow-up of participants over six-months. CTRI/2014/10/005133.
Results
A
total of 104 patients from the stroke unit at Christian Medical
College, Ludhiana were recruited over nine-months. Recruitment was
feasible and accepted by patients and their carers. Important
observations were made regarding potential unblinding of the
participants, contamination of therapy between the randomized groups,
organization of home visits, and resources required for a multicenter
study.
Conclusion
The
pilot study established the feasibility of conducting a large-scale
study of family-led, trained caregiver-delivered, home-based stroke
rehabilitation in a low resource setting. The main phase of the trial
‘ATTEND’ is currently underway in over 10 centers in India.
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