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

Zhengzhou University

Status: Completed

Conditions: Chronic Stroke

Treatments: Other: Skill Building Dyadic Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06827093

NBC-R NO,4-87/NBC-839/23/762 (Other Identifier)

2021-135

Details and patient eligibility

About

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.

Full 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).

Enrollment: 392 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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392 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Other: Skill Building Dyadic Intervention

Controlled group

Other group

Description:

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.

Treatment:

Other: Skill Building Dyadic Intervention