Clinical trial NCT06827093: Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
Official title: Augmented Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Keywords: Stroke survivor
Dyadic intervention
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blind, randomized controlled trials with repeated measures
Primary purpose: PREVENTION

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).

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

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

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Primary outcomes:
measure: promoting the quality of life and care of stroke patients
timeFrame: 12 months of intervention
Secondary outcomes:
measure: Reduces the burden of dyad members
timeFrame: 12 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Dr.Nazia
state: Henan
Study officials:
affiliation: Zhengzhou University Henan China
name: Dr.Nazia Shuaib, PhD
role: PRINCIPAL_INVESTIGATOR
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