CTRI/2017/07/009014
Not yet recruiting
Phase 3
A Randomized Controlled Trial to Evaluate the Effectiveness of the â??Care for Strokeâ?? Intervention in India, a Smartphone-enabled, Carer-supported,Educational intervention for Management of Disabilities following Stroke
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Wellcome Trust DBT India Alliance
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Recent diagnosis of ï¬?rst\-ever stroke as deï¬?ned by the WHO (within 3\-6 weeks prior to recruitment)
- •2\. All kinds of stroke severity (score 1 \- 42, according to NIH stroke scale)
- •3\. Stroke survivor medically stable (reaching a point in medical treatment where life\-threatening problems following stroke have been brought under control)
- •4\. Post\-stroke functional status of the stroke survivor: requiring assistance of at least one person to perform daily activities such as transfers, self\-care and mobility (scoring less than the maximum score obtainable in one or more components of the Barthel Index)
- •5\. Stroke survivor residing with a primary caregiver (family member) at home.
Exclusion Criteria
- •Severe cognitive difficulties (scoring \>1 in Orientation, Executive function, Inattention and Language components of the NIH Stroke Scale for cognition)
- •Severe communication problem (scoring \>1 in Dysarthria and Best Language component of the NIH Stroke Scale)
- •Severe comorbidities (severe psychiatric illness, hearing loss, vision loss)
- •Stroke survivor functionally dependent because of other pre\-existing conditions fracture, dementia)
- •Stroke survivor without a primary caregiver
- •Stroke survivor unwilling/unable to adhere to the study protocol
- •Did not meet the training requirements regarding operation of a smartphone
Outcomes
Primary Outcomes
Not specified
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