Taking Care of Us: A Dyadic Intervention for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
研究概览
简要总结
This research study is evaluating the efficacy and feasibility of a novel, dyadic intervention for heart failure couples versus an educational counseling intervention.
详细描述
There is a critical need for theoretically- and empirically-driven dyadic interventions to improve the outcomes of both adults with heart failure and their partners. The proposed study will evaluate a novel, dyadic program, Taking Care of Us, versus an educational counseling condition using a randomized controlled trial on 72 couples living with heart failure. Both programs are offered via Zoom by trained interventionists and last approximately two months.
Specifically, we will 1) determine the efficacy of the Taking Care of Us intervention on dyadic health; 2) determine the efficacy of the Taking Care of Us intervention on dyadic appraisal and dyadic management; and 3) determine the feasibility and acceptability of the Taking Care of Us intervention.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with Heart Failure:
- •Diagnosis of heart failure for at least three months
- •Current heart failure symptoms (i.e., NYHA Class II-III; AHA/ACC Stage C)
- •Age greater than or equal to 18 years
- •Willing and able to provide informed consent
- •Reachable by telephone/email
- •Access to device with camera (e.g., computer, tablet) to participate in Zoom sessions
- •Have a co-residing spouse/unmarried partner willing to participate
- •Inclusion Criteria: Spouses/Partners:
- •Age greater than or equal to 18 years
- •Co-residing with the adult with heart failure at time of recruitment
- •Have lived with the adult with heart failure for at least one year
- •Willing and able to provide informed consent
排除标准
- •Major and uncorrected hearing impairment
- •Significant cognitive impairment
- •Heart transplantation/mechanical circulatory support prior to enrollment
- •Concomitant terminal illness that would impede participation
- •Active psychosis or severe substance abuse that would impair the ability to complete the study
- •Inability to complete the requirements of the study, including enrolment in an additional trial
研究组 & 干预措施
Taking Care of Us
Taking Care of Us involves seven sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. The program is a communication-based, relationship-focused intervention that is strengths-based and fosters new skills to support couples managing heart failure. The goals of the program are to 1) target the couple with heart failure as a team; 2) increase shared appraisal within the couple; 3) improve communication skills within the couple; 4) improve collaboration within the couple and dyadic management of heart failure; 5) improve confidence within the couple; and 6) improve both individual and dyadic health and well-being.
干预措施: Taking Care of Us (Behavioral)
SUPPORT
The SUPPORT program involves three sessions delivered via Zoom to couples over approximately two months. Sessions last approximately 45-60 minutes and are delivered by a trained interventionist. This arm is an educational intervention to support management of heart failure.
干预措施: SUPPORT (Other)
结局指标
主要结局
Change in Mental Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
时间窗: 5 months after baseline
Mental quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better mental quality of life.
Change in Physical Quality of Life Scores in Couples in the TCU vs SUPPORT Condition.
时间窗: 5 months after baseline
Physical quality of life score from the 10-item PROMIS Global Health Short Form. 4 items recoded to 1-5 scale for potential range of 1-20. Higher scores indicate better physical quality of life.
次要结局
- Change in Heart Failure Related Quality of Life Scores in Persons With Heart Failure in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Care Strain Scores in Spouses in the TCU vs SUPPORT Condition.(5 months after baseline)
- Change in Difference in Pain Interference Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Collaboration Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Difference in Fatigue Scores in Couples in the TCU vs SUPPORT Condition.(5 months baseline)
- Change in Depressive Symptom Scores in Couples in the TCU vs SUPPORT Condition.(5 months after baseline)
- Change in Difference in Dyspnea Scores in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Confidence Scores in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Communication Scores on the Active Engagement Subscale in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
- Change in Communication Scores on the Protective Buffering Subscale in Couples in the TCU vs SUPPORT Condition(5 months after baseline)
研究者
Karen Lyons
Associate Professor
Boston College