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

NCT06827093 | Completed

• 2 other identifiers: 2021-135NBC-R NO,4-87/NBC-839/23/762
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Stroke survivor; Dyadic intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months of intervention

Secondary Outcomes (1)

• Reduces the burden of dyad members

  12 months

Study Arms (2)

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

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.

Other: Skill Building Dyadic Intervention

Interventions

Skill Building Dyadic Intervention OTHER

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.

Controlled group; Experimental group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• The presence of psychiatric morbidity before and after stroke, which specifically includes manic disorders, schizophrenia
• \. having an age greater than 80 years 2. Acute illness

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Dr.Nazia

Zhengzhou, Henan, 454850, China

Location

Related Publications (15)

• 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.

  PMID: 25318537 BACKGROUND

• Pucciarelli 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.

  PMID: 30883880 BACKGROUND

• Dharma 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.

  PMID: 31406848 BACKGROUND

• McCurley 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.

  PMID: 30421266 BACKGROUND

• Shaffer 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.

  PMID: 27513536 BACKGROUND

• Pucciarelli 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.

  PMID: 29700840 BACKGROUND

• Shyu 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.

  PMID: 18800991 BACKGROUND

• Catangui 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.

  PMID: 22874780 BACKGROUND

• Javier 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.

  PMID: 24526021 BACKGROUND

• Mou 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.

  PMID: 36544154 BACKGROUND

• Ostwald 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.

  PMID: 23594060 BACKGROUND

• Krishnan 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.

  PMID: 28320217 BACKGROUND

• Deyhoul 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.

  PMID: 31473982 BACKGROUND

• Cheng 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.

  PMID: 30059815 BACKGROUND

• Tang 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.

  PMID: 29356339 BACKGROUND

Study Officials

• Dr.Nazia Shuaib, PhD

  Zhengzhou University Henan China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single-blind, randomized controlled trials with repeated measures, The primary investigator trained two qualified nurses in each province continuously for 2 weeks to deliver interventions to promote fairness. Permission was obtained from the tertiary care hospital to check the medical records of the study population and to contact them based on their medical records after 2 weeks of discharge. First, the patients were contacted by telephone for inclusion criteria based on their records and being voluntary participants in the study, and then pretest data was collected. The experimental group were received five sessions, while the control group ere received only routine care. The first post-test was conducted three months after the intervention, the second post-test was conducted six months later, and the third post-test was conducted 12 months later.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blind, randomized controlled trials with repeated measures

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: February 14, 2025
• Study Start: October 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: within 6 to 12 months after completion of my study
• Access Criteria: IPD will be shared upon request, within 6 to 12 months of publication

Locations

CN (1)