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临床试验/NCT05627687
NCT05627687已完成1 期

Caring Relationships Expression Study (CARES)

Arizona State University2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2021年12月13日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
38
试验地点
2
主要终点
Perceived Stress Scale-10 (PSS-10)

研究概览

简要总结

This study will examine a heart rate variability biofeedback (HRVB) intervention versus a music listening control (MLC) for 30 family caregivers (FCGs) of Alzheimer's disease (AD) (and related dementias: ADRD) patients to examine feasibility (acceptability/adherence, satisfaction) and direction of change in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality over the course of 8-weeks.

详细描述

This pilot study aims to examine feasibility of implementing a HRVB intervention and an MLC control with AD FCGs. The HRVB and MLC interventions will be evaluated for acceptability (operationalized as adherence to intervention) and satisfaction and to identify necessary intervention modifications. Feasibility benchmarks: 85% of participants will be at least 70% adherent to implementation goals (10-min use 5-7 days per week). Feasibility of randomization will be examined by comparing adherence/retention (expecting similar patterns across interventions). Acceptability/satisfaction with HRVB and MLC will be evaluated in semi-structured interviews post-intervention including detailed probing on feature preferences, barriers/facilitators, suggested improvements for retention.

The second aim of this study is to examine patterns of association of HRVB and MLC with outcomes. The investigators will examine pre- to post-intervention changes (and sustained outcomes at follow-up) in self-reported caregiver burden, stress and resilience. Change in relationship quality will additionally be assessed from pre- to post intervention. Change in ANS balance, a neurophysiological indicator of reduced emotional distress and improved resilience, will be assessed using HRV data at all four timepoints to examine trends and change over time. Significance tests will not be conducted, in alignment with goals for pilot feasibility studies. The investigators will observe the direction of change and outcomes to examine the value of MLC as an appropriate control condition showing minimal placebo effects compared to HRVB.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

The participant is advised that they are entering a study in which they will be randomized to one of two conditions designed to potentially reduce stress and caregiver burden. Neither condition is presented as the control, thus participants are blinded to the expectations of the assigned condition.

入排标准

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

入选标准

  • In primary/unpaid FCG role > 6 months
  • Caring for mild-to-severe ADRD patient
  • 4 caregiver burden score Own/operate smartphone w data plan

排除标准

  • Pacemakers or implanted cardioconverter defibrillator (ICD), or conditions/meds that interfere with HRV measurement/feedback

结局指标

主要结局

Perceived Stress Scale-10 (PSS-10)

时间窗: Change from baseline to 8 weeks at end of intervention

10 items describing stress, response format 0-4, total score range 0-40, higher scores indicating worse stress

Caregiver Burden

时间窗: Change from baseline to 8 weeks at end of intervention

The Zarit Burden Interview includes 12 items, scoring from 0 to 4 (total range 0 to 48) with higher scores indicating higher perceived caregiver Burden

次要结局

  • The Brief Resilience Scale(Change from baseline to 8 weeks at end of intervention)
  • Self-Compassion Scale(Change from baseline to 8 weeks at end of intervention)
  • Depression(Change from baseline to 8 weeks at end of intervention)
  • Relationship Quality(Change from baseline to 8 weeks at end of intervention)

研究者

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

Linda Larkey

Professor

Arizona State University

研究点 (2)

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