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临床试验/NCT05185271
NCT05185271已完成不适用

Adopting Dyad-focused Strategy Training to Stroke Survivors and Their Caregivers: Intervention Development and a Feasibility Study

Taipei Medical University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2021年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Pittsburgh Rehabilitation Participation Scale (PRPS)

研究概览

简要总结

The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases.

In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.

A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited.

The participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes at baseline, post-intervention, and 3-month and 6-month follow-ups. Quantitative data will be analyzed descriptively.

详细描述

Stroke is the leading cause of death and adult disability. Transitioning from hospital to home is a challenging process for stroke survivors and their families, leading to frustration and adverse health outcomes for survivors and caregivers. To address both the survivor and caregiver needs, dyad-focused interventions are necessary to be implemented in the transitioning process. However, very few interventions were designed to address the needs of the dyad and place an equal emphasis on both survivors' and caregivers' outcomes.

The purpose of this study is to develop a dyad-focused intervention built upon the theoretical tenets of strategy training to help prepare stroke survivors and their caregivers to transit to community living. The study will involve two phases. In phase one, the intervention protocol will be developed through literature review, expert panel meeting, and focus groups with rehabilitation therapists, stroke survivors, and caregivers. In phase two, a feasibility study will be conducted to evaluate the acceptability and suitability of this newly-developed intervention and outcome measures to stroke survivor-caregiver dyads.

A mixed-methods (quantitative and qualitative) design, including a repeated measures design, will be used in this feasibility study. Fifteen to twenty stroke survivor-caregiver dyads are expected to be recruited. Adult stroke survivors who have been diagnosed with stroke, are about to be discharged from inpatient wards to home or has been discharged home within the past 3 months, have an identified adult caregiver who provides care or assistance of any kind and taking responsibility for the survivor and is available to participate in the intervention sessions with the survivor will be eligible to participate in the study. These participants will receive the dyad-focused strategy training intervention using the developed intervention protocol. Standardized assessments will be used to assess dyadic outcomes such as goal attainment, quality of life, self-efficacy, participation, depressive symptoms, and survivor-caregiver relationship at baseline, post-intervention, and 3-month and 6-month follow-ups. The feasibility indicators, such as recruitment rates and intervention attendance and adherence, will be evaluated by questionnaires, field notes, and qualitative interviews after the interventions are completed.

Quantitative data will be analyzed descriptively; while data obtained from the outcome measures will be examined using Wilcoxon signed rank test and effect size (r) to compare the differences between the pre- and post-intervention scores. Qualitative data will be analyzed using thematic analysis method.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke survivors include that the survivor:
  • ages 20 years and older;
  • has been diagnosed with stroke;
  • speaks Mandarin;
  • is about to be discharged from inpatient wards to home or has been discharged home within the past 3 months;
  • has an identified primary caregiver;
  • is able to provide informed consent.
  • Caregivers include that the caregiver:
  • ages 20 years and older;
  • speaks Mandarin;
  • is the primary caregiver recognized by the survivor (living with the survivor or providing daily care to the survivor for at least 10 hours per week);
  • is available to participate in the intervention sessions with the survivor;
  • is able to provide informed consent.

排除标准

  • requires significant medical treatment (e.g., chemotherapy, radiation therapy, or hemo/peritoneal dialysis) that may impede them from participating in the study;
  • has severe aphasia;
  • is unable to participate in a 1-hour discussion session;
  • has a diagnosis of dementia, major depressive disorder, substance use or other psychiatric disorders that may impede them from continually participating in the study.

结局指标

主要结局

Pittsburgh Rehabilitation Participation Scale (PRPS)

时间窗: During intervention, up to 2 months

The PRPS, a clinician-rated instrument, measures patients' participation on a 6-point Likert-type scale. A higher point reflects better participation in each intervention session.

Client Satisfaction Questionnaire (CSQ)

时间窗: Immediately after intervention

The CSQ is an 8-item measure of client satisfaction with the intervention. It allows clients to rate on a 4-point scale where 1 represents "Not at all" and 4 represents "Extremely ." A higher score reflects higher satisfaction and acceptability of the intervention.

Qualitative data

时间窗: After intervention

Qualitative data will be collected through field notes taken by therapists after each intervention session and in-person qualitative interviews with participants and their therapists using semi-structured questionnaires.

次要结局

  • Hospital Anxiety and Depression Scale (HADS)(Change from 3-month to 6-month follow-up)
  • Trail-Making Test (TMT A and B)(Change from 3-month to 6-month follow-up)
  • Goal Attainment Scaling (GAS)(Change from baseline to immediately post-intervention)
  • Montreal Cognitive Assessment (MoCA)(Change from 3-month to 6-month follow-up)
  • Preparedness for Caregiving Scale (CPS)(Change from 3-month to 6-month follow-up)
  • World Health Organization Quality of Life (WHOQOL-Brief) Taiwan version(Change from 3-month to 6-month follow-up)
  • General Self-Efficacy Scale (GSES)(Change from 3-month to 6-month follow-up)
  • Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D)(Change from 3-month to 6-month follow-up)
  • Dyadic Relationship Scale (DRS)(Change from 3-month to 6-month follow-up)
  • Activity Measure for Post-Acute Care (AM-PAC) Short Forms(Change from post-intervention to 3-month follow-up)
  • Activity Measure for Post-Acute Care Short Forms(Change from 3-month to 6-month follow-up)
  • Stroop Test(Change from 3-month to 6-month follow-up)
  • The Zarit Burden Interview (ZBI)(Change from 3-month to 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Feng-Hang Chang

Professor

Taipei Medical University

研究点 (1)

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