Chronic StrokeNCT06827093
Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
A study testing Skill Building Dyadic Intervention in people with Chronic Stroke, run by Zhengzhou University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Skill Building Dyadic Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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,
- Able to speak
- Urdu speaker
- Care partners include aphasic patients and demented patients.
- No significant physical or psychological disability
- Be willing and able to provide support to patients after discharge
Who cannot join
- Acute illness (i.e., dementia, advanced cancer, hepatic or renal failure or fractured lower extremity)
- Preexisting diseases before stroke
- Life expectancy of 6 months or less.
- Post-invasive procedural strokes like CABG, angiography and post-operative stroke
- 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
- History of ongoing psychoactive substance abuse, terminal illnesses like renal failure or end-stage cancer
Show all 9Show fewer
- The presence of psychiatric morbidity before and after stroke, which specifically includes manic disorders, schizophrenia
- 1. having an age greater than 80 years 2. Acute illness
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Stroke
- Being tested
- Skill Building Dyadic Intervention
- Keywords
- Stroke survivor, Dyadic intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skill Building Dyadic InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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 Receives: Other: Skill Building Dyadic Intervention |
| Controlled group | Other | 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. Receives: Other: Skill Building Dyadic Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
promoting the quality of life and care of stroke patients
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.
Measured: 12 months of intervention
Secondary outcomes (1)
Reduces the burden of dyad members
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start1 Oct 2021
- Primary completion1 Sep 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, randomized controlled trials with repeated measures
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazia Shuaib, Zhengzhou University
- Investigators
- Dr.Nazia Shuaib, PhD, Principal investigator, Zhengzhou University Henan China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827093
- Sponsor's protocol ID
- 2021-135
- Other IDs
- NBC-R NO,4-87/NBC-839/23/762
- Status last verified
- Feb 2025
- First submitted
- 12 Aug 2024
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Arntzen C, Borg T, Hamran T. Long-term recovery trajectory after stroke: an ongoing negotiation between body, participation and self. Disabil Rehabil. 2015;37(18):1626-34. doi: 10.3109/09638288.2014.972590. Epub 2014 Oct 16.
PubMed 25318537Pucciarelli G, Ausili D, Rebora P, Arisido MW, Simeone S, Alvaro R, Vellone E. Formal and informal care after stroke: A longitudinal analysis of survivors' post rehabilitation hospital discharge. J Adv Nurs. 2019 Nov;75(11):2495-2505. doi: 10.1111/jan.13998. Epub 2019 Apr 22.
PubMed 30883880Dharma KK, Damhudi D, Yardes N, Haeriyanto S. Increase in the functional capacity and quality of life among stroke patients by family caregiver empowerment program based on adaptation model. Int J Nurs Sci. 2018 Sep 7;5(4):357-364. doi: 10.1016/j.ijnss.2018.09.002. eCollection 2018 Oct 10.
PubMed 31406848McCurley JL, Funes CJ, Zale EL, Lin A, Jacobo M, Jacobs JM, Salgueiro D, Tehan T, Rosand J, Vranceanu AM. Preventing Chronic Emotional Distress in Stroke Survivors and Their Informal Caregivers. Neurocrit Care. 2019 Jun;30(3):581-589. doi: 10.1007/s12028-018-0641-6.
PubMed 30421266Shaffer KM, Riklin E, Jacobs JM, Rosand J, Vranceanu AM. Mindfulness and Coping Are Inversely Related to Psychiatric Symptoms in Patients and Informal Caregivers in the Neuroscience ICU: Implications for Clinical Care. Crit Care Med. 2016 Nov;44(11):2028-2036. doi: 10.1097/CCM.0000000000001855.
PubMed 27513536Pucciarelli G, Ausili D, Galbussera AA, Rebora P, Savini S, Simeone S, Alvaro R, Vellone E. Quality of life, anxiety, depression and burden among stroke caregivers: A longitudinal, observational multicentre study. J Adv Nurs. 2018 Apr 27. doi: 10.1111/jan.13695. Online ahead of print.
PubMed 29700840Shyu YI, Maa SH, Chen ST, Chen MC. Quality of life among older stroke patients in Taiwan during the first year after discharge. J Clin Nurs. 2009 Aug;18(16):2320-8. doi: 10.1111/j.1365-2702.2008.02458.x. Epub 2008 Sep 17.
PubMed 18800991Catangui EJ, Slark J. Nurse-led ward rounds: a valuable contribution to acute stroke care. Br J Nurs. 2012 Jul 12-25;21(13):801-5. doi: 10.12968/bjon.2012.21.13.801.
PubMed 22874780Javier Catangui E, John Roberts C. The lived experiences of nurses in one hyper-acute stroke unit. Br J Nurs. 2014 Feb 13-26;23(3):143-8. doi: 10.12968/bjon.2014.23.3.143.
PubMed 24526021Mou H, Lam SKK, Chien WT. Effects of a family-focused dyadic psychoeducational intervention for stroke survivors and their family caregivers: a pilot study. BMC Nurs. 2022 Dec 21;21(1):364. doi: 10.1186/s12912-022-01145-0.
PubMed 36544154Ostwald SK, Godwin KM, Cron SG, Kelley CP, Hersch G, Davis S. Home-based psychoeducational and mailed information programs for stroke-caregiving dyads post-discharge: a randomized trial. Disabil Rehabil. 2014;36(1):55-62. doi: 10.3109/09638288.2013.777806. Epub 2013 Apr 17.
PubMed 23594060Krishnan S, Pappadis MR, Weller SC, Fisher SR, Hay CC, Reistetter TA. Patient-centered mobility outcome preferences according to individuals with stroke and caregivers: a qualitative analysis. Disabil Rehabil. 2018 Jun;40(12):1401-1409. doi: 10.1080/09638288.2017.1297855. Epub 2017 Mar 21.
PubMed 28320217Deyhoul N, Vasli P, Rohani C, Shakeri N, Hosseini M. The effect of family-centered empowerment program on the family caregiver burden and the activities of daily living of Iranian patients with stroke: a randomized controlled trial study. Aging Clin Exp Res. 2020 Jul;32(7):1343-1352. doi: 10.1007/s40520-019-01321-4. Epub 2019 Aug 31.
PubMed 31473982Cheng HY, Chair SY, Chau JPC. Effectiveness of a strength-oriented psychoeducation on caregiving competence, problem-solving abilities, psychosocial outcomes and physical health among family caregiver of stroke survivors: A randomised controlled trial. Int J Nurs Stud. 2018 Nov;87:84-93. doi: 10.1016/j.ijnurstu.2018.07.005. Epub 2018 Jul 28.
PubMed 30059815Tang SH, Chio OI, Chang LH, Mao HF, Chen LH, Yip PK, Hwang JP. Caregiver active participation in psychoeducational intervention improved caregiving skills and competency. Geriatr Gerontol Int. 2018 May;18(5):750-757. doi: 10.1111/ggi.13246. Epub 2018 Jan 22.
PubMed 29356339
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmented Dyadic Interventions to Boost Quality of Life Among Stroke Survivors and Care Partners in Pakistan.
- ClinicalTrials.gov ID
- NCT06827093
- Acronym / sponsor ID
- 2021-135
- Conditions
- Chronic Stroke
- Keywords
- Stroke survivor, Dyadic intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- single-blind, randomized controlled trials with repeated measures
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Skill Building Dyadic InterventionThis 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 |
| Controlled group | Other | Other: Skill Building Dyadic InterventionWhile 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- The study includes stroke survivors:
- While the inclusion criteria for care partners was an identified primary care partner greater than 18 years of age,
- Able to speak
- Urdu speaker
- Care partners include aphasic patients and demented patients.
Key exclusion criteria (9 listed)
- Acute illness (i.e., dementia, advanced cancer, hepatic or renal failure or fractured lower extremity)
- Preexisting diseases before stroke
- Life expectancy of 6 months or less.
- Post-invasive procedural strokes like CABG, angiography and post-operative stroke
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skill Building Dyadic InterventionThe 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, Experimental group |
Primary outcome
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.
1 secondary outcome
Reduces the burden of dyad members
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Background: PubMed 25318537Arntzen C, Borg T, Hamran T. Long-term recovery trajectory after stroke: an ongoing negotiation between body, participation and self. Disabil Rehabil. 2015;37(18):1626-34. doi: 10.3109/09638288.2014.972590. Epub 2014 Oct 16.
- Background: PubMed 30883880Pucciarelli G, Ausili D, Rebora P, Arisido MW, Simeone S, Alvaro R, Vellone E. Formal and informal care after stroke: A longitudinal analysis of survivors' post rehabilitation hospital discharge. J Adv Nurs. 2019 Nov;75(11):2495-2505. doi: 10.1111/jan.13998. Epub 2019 Apr 22.
- Background: PubMed 31406848Dharma KK, Damhudi D, Yardes N, Haeriyanto S. Increase in the functional capacity and quality of life among stroke patients by family caregiver empowerment program based on adaptation model. Int J Nurs Sci. 2018 Sep 7;5(4):357-364. doi: 10.1016/j.ijnss.2018.09.002. eCollection 2018 Oct 10.
- Background: PubMed 30421266McCurley JL, Funes CJ, Zale EL, Lin A, Jacobo M, Jacobs JM, Salgueiro D, Tehan T, Rosand J, Vranceanu AM. Preventing Chronic Emotional Distress in Stroke Survivors and Their Informal Caregivers. Neurocrit Care. 2019 Jun;30(3):581-589. doi: 10.1007/s12028-018-0641-6.
- Background: PubMed 27513536Shaffer KM, Riklin E, Jacobs JM, Rosand J, Vranceanu AM. Mindfulness and Coping Are Inversely Related to Psychiatric Symptoms in Patients and Informal Caregivers in the Neuroscience ICU: Implications for Clinical Care. Crit Care Med. 2016 Nov;44(11):2028-2036. doi: 10.1097/CCM.0000000000001855.
- Background: PubMed 29700840Pucciarelli G, Ausili D, Galbussera AA, Rebora P, Savini S, Simeone S, Alvaro R, Vellone E. Quality of life, anxiety, depression and burden among stroke caregivers: A longitudinal, observational multicentre study. J Adv Nurs. 2018 Apr 27. doi: 10.1111/jan.13695. Online ahead of print.
- Background: PubMed 18800991Shyu YI, Maa SH, Chen ST, Chen MC. Quality of life among older stroke patients in Taiwan during the first year after discharge. J Clin Nurs. 2009 Aug;18(16):2320-8. doi: 10.1111/j.1365-2702.2008.02458.x. Epub 2008 Sep 17.
- Background: PubMed 22874780Catangui EJ, Slark J. Nurse-led ward rounds: a valuable contribution to acute stroke care. Br J Nurs. 2012 Jul 12-25;21(13):801-5. doi: 10.12968/bjon.2012.21.13.801.
- Background: PubMed 24526021Javier Catangui E, John Roberts C. The lived experiences of nurses in one hyper-acute stroke unit. Br J Nurs. 2014 Feb 13-26;23(3):143-8. doi: 10.12968/bjon.2014.23.3.143.
- Background: PubMed 36544154Mou H, Lam SKK, Chien WT. Effects of a family-focused dyadic psychoeducational intervention for stroke survivors and their family caregivers: a pilot study. BMC Nurs. 2022 Dec 21;21(1):364. doi: 10.1186/s12912-022-01145-0.
- Background: PubMed 23594060Ostwald SK, Godwin KM, Cron SG, Kelley CP, Hersch G, Davis S. Home-based psychoeducational and mailed information programs for stroke-caregiving dyads post-discharge: a randomized trial. Disabil Rehabil. 2014;36(1):55-62. doi: 10.3109/09638288.2013.777806. Epub 2013 Apr 17.
- Background: PubMed 28320217Krishnan S, Pappadis MR, Weller SC, Fisher SR, Hay CC, Reistetter TA. Patient-centered mobility outcome preferences according to individuals with stroke and caregivers: a qualitative analysis. Disabil Rehabil. 2018 Jun;40(12):1401-1409. doi: 10.1080/09638288.2017.1297855. Epub 2017 Mar 21.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr.Nazia Shuaib, PhD principal investigator
Zhengzhou University Henan China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skill Building Dyadic Intervention in people with Chronic Stroke, run by Zhengzhou University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
promoting the quality of life and care of stroke patients (time frame: 12 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06827093, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.