Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06827093
Status:
COMPLETED
Last Update Posted:
2025-02-14
First Post:
2024-08-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
Sponsor:
Zhengzhou University
Organization:
Study Overview
Official Title:
Augmented Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
Status:
COMPLETED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NBC-R NO,4-87/NBC-839/23/762 | OTHER | National bioethical committee for research(NBC-R) | View |