Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.

NCT ID: NCT06827093

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 392 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-12-01

Brief Summary

This study (RCTs) will be conducted on stroke survivors and their care partners after discharge from the hospital. The study will aim to evaluate the impact of augmented dyadic intervention on the quality of life of stroke survivors and caregiver burden. A randomized control trial with a parallel group design will be used for the study. The design used for the current study will be single-blind, randomized controlled trials with repeated measures. Each group will include 196 subjects (98 stroke survivors and 98 care partners). The total number of individuals will be 392, including 196 stroke survivors and 196 care partners. Stroke survivors will have an age range of 18-75 years and both genders with a confirmed diagnosis of stroke. The goal of this study will be to rehabilitate patients with disability, there is a dire need for dyad interventions to support and train stroke care partners by providing education, counselling, emotional support and access to health services. The hypothesis of this (RCTs )is that there is no relationship between stress and quality of life for improvement in quality of life through dyadic intervention.

Detailed Description

Stroke is a leading cause of mortality and disability around the world, leaving survivors with significant physical deficits and resulting in a variety of psychological problems as well as social constraints and retreats for both the survivors and their families. The study population will be stroke survivors and their care partners after discharge from the hospital. The design will be single-blind, randomized controlled trials with repeated measures. A total of 392 participants will be recruited voluntarily, of which 196 will be randomly assigned to the control group and 196 to the intervention group. A five-session intervention containing three face-to-face and two telephonic sessions will be delivered. A valid and reliable stroke-specific quality of life questionnaire for stroke survivors and Zarit Burden and an interview for caregiver burden will be used. The primary investigator will train two qualified nurses in each province for 2 weeks to deliver interventions to promote fairness. Permission will be obtained from the tertiary care hospital to check the medical records for the study population and to contact them based on their medical records after 2 weeks of discharge. First, the patients will be contacted by telephone for inclusion criteria based on their records and being voluntary participants in the study, and then pretest data will be collected. The experimental group will receive five sessions, while the control group will receive routine care. The first post-test will be conducted three months after the intervention, the second post-test will be conducted six months later, and the third post-test will be conducted 12 months later Data analysis will be performed through SPSS 22 as descriptive (frequency and percentages for categorical variables, while the mean and standard deviation for continuous variables) and inferential statistics (independent t-test for differences between the groups and Pearson correlation for association with demographic variables).

Conditions

Chronic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental group

This program's protocol will consist of Part I (three structured in-person education sessions) and Part II (two telephone follow-up sessions). The session and content of the intervention will be:

Session 1 (Two weeks after discharge) Introduction to stroke and different aspects of management: Session 2 (three weeks after discharge)

Promotion of care and demonstration of self-care activities:

Demonstration and skill development Session 3 (Four weeks after discharge) Psychological adjustment and management: Session 4 (2 weeks later from 3rd session) Telephonic session: The aim of communicating with the dyad through the telephone is to provide the information required for psychological support, behavioural regulation and emotional support.

Session 5 (2 weeks later from 3rd session) Followup telephonic session: Promoting activities and assistance

Group Type: EXPERIMENTAL

Skill Building Dyadic Intervention

Intervention Type: OTHER

The focal point of skill-building interventions contains some strategies that facilitate problem-solving, goal setting, communicating with care experts, stress management, hands-on training in such skills (lifting and mobility techniques and assistance with activities of daily living), and modification of communication according to the needs of stroke survivors.

Controlled group

While the control group will receive their routine care. The first post-test will be conducted three months after the intervention, the second post-test will be conducted six months later, and the third post-test will be conducted 12 months later. The inclusion and exclusion criteria for the patient and caregiver will be the same.

Group Type: OTHER

Skill Building Dyadic Intervention

Intervention Type: OTHER

The focal point of skill-building interventions contains some strategies that facilitate problem-solving, goal setting, communicating with care experts, stress management, hands-on training in such skills (lifting and mobility techniques and assistance with activities of daily living), and modification of communication according to the needs of stroke survivors.

Interventions

Skill Building Dyadic Intervention

The focal point of skill-building interventions contains some strategies that facilitate problem-solving, goal setting, communicating with care experts, stress management, hands-on training in such skills (lifting and mobility techniques and assistance with activities of daily living), and modification of communication according to the needs of stroke survivors.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• The study includes stroke survivors:

• Having an age range of 18-75 years with a confirmed diagnosis of stroke (confirmed by a neurologist with radiological evidence by either CT scan and/or MRI) and meeting the following eligibility criteria was required. 26
• Having a diagnosis of stroke More than 15 days
• Stable, non-fluctuating stroke with no acute, ongoing neurological
• No preexisting disability before stroke (defined by mRS =0).
• Independent in daily living activities before the stroke
• Expected to return home with residual disability

1. Able to speak

2. Urdu speaker

3. Care partners include aphasic patients and demented patients.

4. No significant physical or psychological disability

5. Be willing and able to provide support to patients after discharge

Exclusion Criteria

1. Acute illness (i.e., dementia, advanced cancer, hepatic or renal failure or fractured lower extremity)

2. Preexisting diseases before stroke

3. Life expectancy of 6 months or less.

4. Post-invasive procedural strokes like CABG, angiography and post-operative stroke

5. Global aphasia and/or being unable to communicate. Dementia on the Mini-Mental State Examination (of <22) (due to inability to directly communicate) 26,27

6. History of ongoing psychoactive substance abuse, terminal illnesses like renal failure or end-stage cancer

7. The presence of psychiatric morbidity before and after stroke, which specifically includes manic disorders, schizophrenia

1. having an age greater than 80 years 2. Acute illness

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhengzhou University

OTHER

Sponsor Role: lead

Responsible Party

Nazia Shuaib

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr.Nazia Shuaib, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhengzhou University Henan China

Locations

Dr.Nazia

Zhengzhou, Henan, China

Countries

China

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NBC-R NO,4-87/NBC-839/23/762

Identifier Type: OTHER

Identifier Source: secondary_id

2021-135

Identifier Type: -

Identifier Source: org_study_id