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

February 12, 2025 updated by: Nazia Shuaib, Zhengzhou University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

392

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

  • China
    • Henan
      • Zhengzhou, Henan, China, 454850
        • Dr.Nazia

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

While the inclusion criteria for care partners was an identified primary care partner greater than 18 years of age,

  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: Exclusion criteria for stroke survivors

  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

Exclusion criteria for family caregivers

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

-

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
promoting the quality of life and care of stroke patients
Time Frame: 12 months of intervention
This study will evaluate the effects of a skill-building dyadic intervention on improving the quality of life (QOL) for 392 individuals, consisting of 196 stroke survivors and their 196 care partners. The study will utilize a 49-item stroke-specific questionnaire to assess the quality of life of stroke survivors across 12 domains. This comprehensive tool will provide valuable insights into the various aspects of stroke survivors' lives. The study's outcome is expected to reveal significant improvements in the quality of life of stroke survivors. After receiving the intervention, participants will report enhanced knowledge, satisfaction, and self-efficacy. Specifically, the study will find positive impacts on energy, mobility, mood, and treatment efficacy, ultimately leading to an improved quality of life for stroke survivors.
12 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduces the burden of dyad members
Time Frame: 12 months
The Zarit Burden Interview (ZBI) will assess caregiver burden using a modified 22-item scale. This scale will feature a 5-point Likert scale (0-4) across four domains: confidence, competence, quality of care, and self-efficacy. Data analysis will utilize Pearson correlation through SPSS 26.0 to explore the relationship between stroke survivors and caregiver burden with demographic variables. This study aims to reduce stroke survivors' and caregivers' psychological, social, and financial burdens. A single-blind, randomized controlled trial with 392 participants (196 stroke survivors, 196 care partners) will test a 5-session intervention, with data collection at pre-intervention, and post-intervention (3, 6, 12 months).
12 months

Collaborators and Investigators

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

Sponsor

Zhengzhou University

Investigators

  • Principal Investigator: Dr.Nazia Shuaib, PhD, Zhengzhou University Henan China

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 (Actual)

October 1, 2021

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

February 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-135
  • NBC-R NO,4-87/NBC-839/23/762 (Other Identifier: National bioethical committee for research(NBC-R))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share individual participant data (IPD) from this clinical trial to facilitate further research and transparency."Individual participant data (IPD) will be shared upon request, following publication of primary results, through a secure online platform, with terms outlined in a data use agreement.

IPD Sharing Time Frame

within 6 to 12 months after completion of my study

IPD Sharing Access Criteria

IPD will be shared upon request, within 6 to 12 months of publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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