Easing the Burden of Dementia Caregiving: A Telephone-delivered Mindfulness Intervention for Rural, African American Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Number of Participants Attending at Least 6 Telephone Sessions
研究概览
简要总结
This study is assesses the feasibility and acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden for African-American rural caregivers of individuals with moderate to severe dementia, as defined by the caregiver. The study utilizes a single-group, uncontrolled design to test the feasibility and acceptability of the intervention for the target population.
详细描述
Mindfulness interventions can decrease caregiver burden and improve coping skills, including decreased emotion-based coping, increased tolerance for uncertainty, improved psychological well-being and quality of life while potentially improving relationship quality and communication.
This study utilizes a single-group, uncontrolled design to assess the feasibility and acceptability of telephone-delivered mindfulness training designed to alleviate caregiver burden for African-American rural caregivers of individuals with moderate to severe dementia, as defined by the caregiver. The telephone-delivered mindfulness intervention will improve geographical access for rural caregivers and deem more flexible for a caregiver's schedule. The study's intervention consists of mindfulness training delivered by telephone once weekly for 8 weeks. The intervention also includes one retreat for which respite care will be provided, if needed. The intervention, based on, Kabat-Zinn's mindfulness-based stress reduction (MBSR), will emphasize the following: 1) mindful experiencing, including mindfulness of feelings and body sensations; 2) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and 3) mindful compassion for self and others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •The candidate is at least 18 years old;
- •The candidate self-identifies as Black or African American;
- •The candidate provides at least 4 hours of care per day to the care recipient, who must have either a diagnosis of dementia OR have a score of at least 2 or higher on the Alzheimer's Disease Screening tool (AD-8) or a score of 8 or higher on the Functional Assessment Staging of Alzheimer's disease (FAST) scale (indicative of moderate - severe dementia);
- •The candidate is able to identify and recruit an additional informal caregiver (care partner) to participate in the study. The care partner must consider themselves as part of the caregiving team that helps to make decisions about the care of the care recipient. The care partner may be a blood relative or close friend, but not a formal caregiver. The care partner need not live in the same geographic area.
- •Both the candidate primary caregiver and care partner must have access to a telephone and express a willingness to participate in the pre- and post-participation assessments, the intervention calls, and the intervention retreat.
排除标准
- •The candidate is too unwell to participate; e.g., with an active diagnosis of cancer or more than 3 hospitalizations in the past year;
- •The primary caregiver is unable to identify and recruit a care partner willing to commit to the study requirements;
- •The care recipient does not meet the criteria for dementia.
结局指标
主要结局
Number of Participants Attending at Least 6 Telephone Sessions
时间窗: 8 weeks
The instructor will conduct a role call to take attendance at the beginning of each of the 8 class sessions and 1 retreat session. Eighty-five percent of participants who start the intervention will complete at least 6 out of 9 intervention sessions. Attendance used as a proxy to assess intervention acceptability.
Percent of Dyads Who Endorse the Program
时间窗: 8 weeks
The intervention will be acceptable to informal caregiving teams as evidenced by an 85 percent (95% Confidence Interval (CI): 72.5, 97.5) endorsement of the program in post-participation interviews. Calculated based on responses to open-ended questions regarding participants' experiences of the intervention. Examples of questions are: "how valuable or beneficial was the mindfulness training to you?" and "what challenges did you have with the training?" and "what did you expect from the training that you did not get?". Endorsement was considered positive if the expressions of value outweighed challenges (i.e., positive comments outweighed negative comments by dyad). Data reported as caregiving teams (dyads) in accordance with the protocol.
次要结局
- Change From Baseline in the Family Satisfaction Scale (FSS) Score(up to 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Acceptance)(Baseline, 8 weeks)
- Change From Baseline in the Zarit Burden Interview Short Form (ZBI-12) Score(Baseline, 8 weeks)
- Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Prospective Subscale Score(up to 8 weeks)
- Change From Baseline in Intolerance of Uncertainty Scale (IUS-12) Inhibitory Subscale Score(up to 8 weeks)
- Change From Baseline on PROMIS Meaning and Purpose-Short Form 6a(Baseline, 8 weeks)
- Change From Baseline on Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(Baseline, 8 weeks)
- Change From Baseline on PROMIS Global Physical Health(Baseline, 8 weeks)
- Change From Baseline on PROMIS Emotional Distress-Anger-Short Form 5a(Baseline, 8 weeks)
- Change From Baseline on PROMIS General Self-Efficacy-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline in Mean NPI-Q Distress Scores(Baseline, 8 weeks)
- Change From Baseline on PROMIS Self-Efficacy for Managing Emotions-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline on PROMIS Emotional Distress-Anxiety-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Self-Blame)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Other-Blame)(Baseline, 8 weeks)
- Change From Baseline on PROMIS Instrumental Support-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Refocusing)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Planning)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Positive Reappraisal)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Catastrophizing)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Putting Into Perspective)(Baseline, 8 weeks)
- Change From Baseline on Cognitive Emotional Regulation Questionnaire (CERQ)-Short Form (Rumination)(Baseline, 8 weeks)
- Change From Baseline on PROMIS Emotional Support-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline on PROMIS Informational Support-Short Form 4a(Baseline, 8 weeks)
- Change From Baseline in the Family Conflict Scale Attitudes and Actions Toward the Patient Subscale(Baseline, 8 weeks)
- Change From Baseline on Family Conflict Scale (FCS) Actions and Attitudes Toward the Caregiver Subscale(Baseline, 8 weeks)
- Change From Baseline in the Family Conflict Strategies for Care Subscale(Baseline, 8 weeks)