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A study to evaluate the effect of a technology driven educational intervention for management of disabilities following stroke in India

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

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009014
Enrollment
320
Registered
2017-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Stroke /Cerebrovascular Accident (CVA)

Interventions

Intervention1: Smartphone enabled Educational Intervention: The â??Care for Strokeâ?? intervention will be delivered through a smartphone and it will include information about stroke and the ways to m

Sponsors

The Wellcome Trust DBT India Alliance
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Recent diagnosis of �rst-ever stroke as de�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

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

Design outcomes

Primary

MeasureTime frame
Dependency / Disability Outcome assessment Name: Modified Rankin Scale (score of 0-2) at 3 months after recruitment.Timepoint: 3 and 6 Months

Secondary

MeasureTime frame
1. Modified Barthel Index 2. Modified Caregiver Strain Index 3. Quality of Life measured by WHOQOL BREF 4. Use of Health care and Rehabilitation services (Therapy, Hospitalisation and medication, AYUSH, traditional practices etc.)Timepoint: 3 and 6 Months

Countries

India

Contacts

Public ContactSureshkumar Kamalakannan

Public Health Foundation of India Indian Institute of Public Health Hyderabad

suresh.kumar@iiphh.org04049006023

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 24, 2026