Augmented Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
Phase: NA
Conditions: Chronic Stroke
Sponsor: Zhengzhou University

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
 
 
 
 
 
 
 
Title: 
 
The Effectiveness of Augmented Dyadic Interventions to 
Boost Quality of Life Among Stroke Survivors and 
Preparedness of Care Partners in Pakistan. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Project Summary 
Study Background 
Stroke is a leading cause of mortality and disability worldwide, resulting in significant physical 
deficits and psychological problems for survivors and their families. The impact of stroke can be 
devastating, affecting not only the individual but also their loved ones. 
Study Objective 
1) The objective of the study is to evaluate the efficacy of skill building dyadic intervention 
in improving dyad (care partner based) quality of life after stroke by focusing on the 
quality of life and outcomes of the stroke survivors and their care partners living at home 
post stroke occurrence.  
 
2) To assess and evaluate the effect of outcomes on quality of life of dyad members and 
reducing caregiver burden among stroke survivors and their care partners by using a 
dyadic intervention.  
 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
 Study Design 
This study is classified as an interventional study, with the primary purpose of prevention. The 
study phase is not applicable (N/A). The interventional study model is a parallel assignment, where 
participants will be randomly assigned to either the experimental group or the control group. The 
study will employ single masking, where only the participant will be blinded to the group 
assignment. 
The interventional study design is single-blind, randomized controlled trials with repeated 
measures. Each group will include 196 subjects (98 stroke survivor + 98 care partner). Total no. 
of individuals will be 392 which have 196 stroke survivor and 196 care partners.  Out of 196 pairs 
the 98 pairs will be kept control. After baseline assessment, the responsible assessor will be 
telephoned with patients identification details obtained from hospital, rehabilitation centers of 
Pakistan. Permission from the patients or caregivers will be taken on consent form before the start 
of the assessment.  
 
Randomization 
Participants will be randomly assigned to either the experimental group or the control group. This 
randomization will ensure that the groups are comparable in terms of demographic characteristics, 
reducing the risk of bias and increasing the validity of the results. 
 
Study Population 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
 
This study will be conducted upon stroke survivors and their care partner after discharge from the 
hospital. A care partner is defined as the main person (Spouse, Mother, Father, Sister, Brother, Son 
and Daughter) helping with activities of daily living and advocating on behalf of the stroke 
survivors. A consent form will be obtained from targeted stroke survivors and care partners. 
A total of 392 participants, comprising 196 stroke survivors and 196 care partners, will be recruited 
voluntarily from a tertiary care hospital. The participants will be selected based on specific 
inclusion and exclusion criteria. 
 
 
Inclusion Criteria 
To be eligible for participation, stroke survivors must meet specific criteria. They must be aged 
18-75 years, have a confirmed diagnosis of stroke and be discharged from the hospital. 
Additionally, they must participate voluntarily, be able to speak Urdu, and have no significant 
physical or psychological disability. Furthermore, care partners must be identified as primary care 
partners. 
 
Exclusion Criteria 
 
Participants will be excluded from the study if they meet certain criteria. These include acute 
illness, preexisting diseases before stroke, life expectancy of 6 months or less, global aphasia, and 
dementia on the Mini-Mental State Examination (score <22). Additionally, participants with a 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
history of ongoing psychoactive substance abuse or terminal illnesses like renal failure or end-
stage cancer will be excluded. 
 
Intervention 
Participants will be randomly assigned to either the experimental group or the control group. The 
experimental group will receive a five-session intervention, consisting of three face-to-face 
sessions and two telephonic sessions. In contrast, the control group will receive routine care. A 
five-session intervention will be delivered by trained nurses. The intervention aims to provide 
education, support, skills  and guidance to stroke survivors and their care partners 
 
Table 1: Nurse led Augmented dyadic interventions contents 
Session 
Key Content 
Session 1 
(Two weeks 
later of 
discharge) 
Introduction to stroke and different aspects of management: 
The information on stroke, stroke consequences, prevention, and 
management aspects. Also to enhance the family dyad 
understanding regarding stroke and its effects. 
Duration: 60 mins, Mode: Face to face, Format discussion 
Session 2 
Promotion of care and demonstration of self-care activities: 
(three weeks 
Instructions on the management of pressure areas and prevention 
later of 
of bedsores, dressing   and   how   to   keep   personal   hygiene, 
discharge) 
continence, physical activity, nutrition, positioning, facilitating 
 
transfers, daily living tasks and gait facilitation. It also include the 
 
hands-on training on lifting and handling techniques, facilitation of 
 
mobility and transfers,   continence,   assistance   with personal 
 
activities of daily living and communication, tailored to the needs 
 
of individual patients. 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
 
Duration: 60 mins, Mode: Face to face, Format: Demonstration 
 
and skill development 
 
 
 
 
 
 
 
 
 
Data Collection: 
Data will be collected at multiple time points. Pre-test data will be collected at baseline, followed 
by post-test data at 3, 6, and 12 months after the intervention. Structured interviews and self-
report questionnaires will be used to collect data. 
 
Outcome Measures: 
The study will assess two primary outcomes. For stroke survivors, quality of life will be 
measured using a stroke-specific quality of life questionnaire. For caregivers, burden will be 
assessed using the Zarit Burden Interview. 
 
Statistical Analysis Plan (SAP): 
 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
The Statistical Analysis Plan (SAP) outlines the statistical methods and procedures that will be 
used to analyze the data collected in this study. SPSS 22 will be used for data analysis. 
 
Descriptive statistics will be used to summarize the data, including frequency and percentage for 
categorical variables, and mean and standard deviation for continuous variables. This will provide 
an overview of the characteristics of the study sample and the distribution of the variables. 
 
 
 
Inferential statistics will be used to examine the relationships between variables.. Specifically, 
independent t-tests will be used to compare means between two independent groups (e.g., 
experimental vs. control group), paired t-tests will be used to compare means between two related 
groups (e.g., pre-test vs. post-test scores), and Pearson correlations will be used to examine the 
relationship between two continuous variables. 
 
Data will be collected at four time points: baseline (pre-test), 3 months after the intervention, 6 
months after the intervention, and 12 months after the intervention. This will allow us to examine 
the changes in the outcome variables over time and assess the effectiveness of the intervention. 
The data analysis procedure will involve several steps. First, the data will be cleaned and checked 
for missing values. Then, descriptive statistics will be used to summarize the data. Next, inferential 
statistics will be used to examine the relationships between variables and test hypotheses. Finally, 
the results will be interpreted and conclusions will be drawn. By following this SAP, we aim to 

ID: 2021-135   
 
 
 
                                     Date: 1, October, 2021 
 
The Effectiveness of Augmented Dyadic Interventions to Boost Quality of Life Among 
Stroke Survivors and Preparedness of Care Partners in Pakistan. 
 
ensure that the data analysis is conducted in a systematic and rigorous manner and that the results 
are reliable and generalizable. 
 
 
 
 
 
 

    郑州大学护理与健康学院 
       S c h o o l  o f  N u r s i n g  a n d  H e a l t h  Z h e n g z h o u  U n i v e r s i t y 
 
 
Informed Consent Form (ICF): 
. 
ANNEXURE-I 
CONSENT FORM 
Zhengzhou University Henan China 
 
I_______________________________, son/daughter of__________________________, 
Hereby, fully agree to contribute in the above-mentioned study. My ID No.                                   is 
_______________. I understand that the study is designed to add knowledge to nursing. I have 
been informed about the nature of the participation and possible risks/discomfort involved. I had 
the opportunity to ask any question about the study and I     agree to give my response as requested 
by the researcher (Nazia Shuaib). I have no objection in case the data obtained from my 
investigation is published in a research publication while maintaining confidentiality. 
 
 
 
____________________      ______________________      ________________________ 
(The Supervisor)                            (The researcher)               Signature of the Participant 
 
 
 
 
  
 
 
 
   
 
 
 
 
 
 
 

    郑州大学护理与健康学院 
       S c h o o l  o f  N u r s i n g  a n d  H e a l t h  Z h e n g z h o u  U n i v e r s i t y 
 
Explanation letter for the participants: 
 
                     
 
Explanation letter for the participants 
             Zhengzhou University Henan China 
 
Dear Participants, 
Why is this research being done? 
 
This research focuses on Augmented dyadic interventions to boost quality of life among stroke 
survivors and their care partners in Pakistan. This research is part of a requirement for a PhD in 
nursing at the Zhengzhou University Henan China and is being conducted by NAZIA SHUAIB, 
a PhD Scholar. 
 
Why have you been asked? 
 
You are invited to participate in this study because you are a Care partners of stroke survivors who 
is able to assess and successfully manage stroke survivors at home. Your experience and 
information are very important to give an exact picture of the dyad intervention to enhance quality 
of life of both dyad members. 
 
 Risk/Benefits Ratio: 
 
A questionnaire will be given to you for data collection and assessment regarding SSQOL(stroke 
survivors quality of life ) and Zarit burden scale for care partners as well as a brief demographic 
questionnaire. 
There is no danger/risk factors linked with this study. Your participation in this study is entirely 
on your choice. There may or may not be direct benefits to you but it is hoped that your 
participation will enhance your awareness and knowledge regarding pain after review website of 
answers key. 
Ethical Consideration/Consent: 
 
 Taking part in this study is entirely up to you. You have the right to refuse to participate in this 
study because it will be purely your voluntarily participation Your Confidentiality and privacy 
will be maintained sternly. The collected information will not be shared without your consent. 
 
Participant’s approval: 
 
 
 
Participant’s signature_____________ Date______________ 
 
 
 
 
 
 
 
 
 
 
 
 
Thank you! Your contribution is greatly valued in improving QOL o stroke survivors and 
their care partners at home. 
ANNEXURE-II 

    郑州大学护理与健康学院 
       S c h o o l  o f  N u r s i n g  a n d  H e a l t h  Z h e n g z h o u  U n i v e r s i t y 
 
 
 
 
ETHICAL CONSIDERATIONS 
Zhengzhou University Henan China 
TITLE: Augmented dyadic interventions to boost quality of life among stroke survivors 
and their care partners in Pakistan. 
 
 
 
I undertake that: 
 
I will abide by the declaration of World Medical Association (WMA) make at Helsinki (2008) regarding the ethical 
principles for medical research involving human subjects. 
1. 
The Health of the subject will be the prior consideration. 
2. 
All ethical considerations will be taken care according to the code and ethics review board of the university. 
3. 
Confidentiality and privacy of the participants will be maintained sternly. 
4. 
Proper written consent with all necessary information, will be taken from all the participants to take their voluntarily 
participation. 
5. 
All Procedure shall be kept aseptic and painless. 
6. 
The Confidentiality of the information shall be assured and maintained. 
 
 
 
 
Researcher signature_____________