Promoting Reengagement in Daily Meaningful Activity (PRIMA) Intervention for Adults With Mild Cognitive Impairment and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- Life satisfaction
研究概览
简要总结
The investigators developed and tested the Daily Engagement in Meaningful Activities (DEMA) intervention to improve life satisfaction and health outcomes for patients and caregivers. DEMA is a positive health focused, theoretically grounded, tailored, family-centered, multi-faceted intervention. Over 7 session, dyads work with a nurse to 1) identify meaningful activities, assess capacity, problem-solve barriers, and establish routines for engagement and 2) learn more about MCI by working through six Self-Management Toolkit topics (e.g., benefits of meaningful activity; planning the future). The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
详细描述
Approximately 20% of Americans over 65 have mild cognitive impairment (MCI), defined as experiencing more memory problems than normally expected with aging, but no other symptoms of dementia such as impaired judgment or reasoning. Persons with MCI (patients) are at great risk for developing dementia (10-33% per year). Memory problem (poor executive function) diminish the patient's confidence and ability to perform meaningful and/or important activities (e.g. socialization, medication management).
Deteriorating life satisfaction in patients and care partners (caregivers) is a prevalent problem due to diminished meaningful activity engagement which occurs as a result of patient frustration and embarrassment, lack of self-efficacy (confidence), and diminishing activity performance. As a result, patients experience additional negative health outcomes: 38% report depressive symptoms and anxiety. Caregivers often lack confidence to manage their own and the patient's daily challenges and meaningful activity engagement, leading to high caregiver burden, depressive symptoms, and anxiety. As a dyad, both patients and caregivers report diminished satisfaction within their communication and relationship due to disagreement about the patient's functional ability to effectively and safely perform meaningful activities.
Emerging evidence indicates regular engagement in social, physical or cognitive activities can improve life satisfaction, activity performance, depressive symptoms, anxiety, and dyad communication; health outcomes are even better when the activities are self-selected and meaningful. To promote patients' and caregivers' life satisfaction and health outcomes, interventions to maximize patients' capacity for full engagement in meaningful activities are essential; yet, there is a marked absence of such empirically validated interventions.
The investigators' purpose is to evaluate the efficacy of DEMA in a two-group randomized controlled trial with 210 patient/caregiver dyads (DEMA intervention vs. the information support (IS) attention control group).
2.0 Rationale and Specific Aims.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Following consent, the project manager will arrange a time convenient for patient-caregiver dyads to separately complete the baseline (T1) measures by phone. A data collector, blinded to randomization status, will administer all measures at all time points via phone interviews in a quiet, private setting and be available for questions following data collection. Immediately following completion of the T1 measures; and enter patient scores on the PHQ-9 depression scale directly to the database. A web-based computer-generated stratified randomization scheme will be used to assign the patient-caregiver dyads to DEMA or the information support group in 1:1 ratio using a block-randomized approach stratified on a depression score PHQ-9 ≤ 4 vs. PHQ-9 ≥ 5 or higher will be used to determine the randomization scheme. The Project Manager will immediately schedule Session 1. Only the statistician, PI, project manager, and the intervener will know the patient-caregiver dyad's randomization status.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MCI Patient
- •age greater than 59 years old
- •able to speak and read English
- •access to telephone
- •have both self or informant reported cognitive complaints
- •MoCA score = 15 to 25
- •in the normal range in performance of daily living tasks based on functional impairment absent: a check box of Functional Activities Questionnaire (FAQ) has no score ≥2);
- •Inclusion Criteria: Family caregivers:
- •self-identify as care partner (i.e. spouse, family member or friend)
- •aged greater than or equal to 18 years
- •have primary responsibility for providing care to an MCI patient, along with monitoring safety and providing social support;
- •are able to speak and read English;
- •access to telephone
- •oriented to persons, places, and time (having a 6-item Screener score of 4 or above).
排除标准
- •a diagnosed untreated severe major depression, or receiving advanced cancer treatment or hospice care
- •receiving dialysis
- •severe hearing loss and no hearing aids
- •have no access to a telephone
- •the family caregiver has significant cognitive impairment that may hinder participation (6-item MMSE < 4).
研究组 & 干预措施
Daily Engagement Meaningful Activity (DEMA)
This group will receive 7 telephone sessions over a 12 week period (1st session week, 2-7 bi-weekly) delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.
干预措施: Daily Engagement Meaningful Activity (DEMA) (Behavioral)
Information Support (IS)
This group will attend 7 telephone sessions to receive an overview of what will happen in the study and use selected educational material from the Alzheimer's Association delivered by a trained intervener. The sessions will occur over 12 weeks (1 session at Week 1, bi-weekly from the 2 to 7 sessions) via phone calls. Dyads will have the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
干预措施: Information Support (IS) (Behavioral)
结局指标
主要结局
Life satisfaction
时间窗: Change from Baseline Life Satisfaction at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention
The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately.
Life Satisfaction (LSITA)
时间窗: Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation
The Life Satisfaction Index for the Third Age (LSITA) Scale-Short Form, is a 12-item with a 6-point response scale (ranging from "1" Strongly disagree to "6" strongly agree) (Barrett \& Murk, 2006). It is a measure of the overall construct of Life Satisfaction. It has been commonly used in older populations. Possible range of total scores is 12-72 and higher scores indicate better functioning. The total score ranges from 12 to 72.The reliability of the LSITA-SF scale was .90 (Barrett \& Murk, 2006). The scale takes about 3 minutes to complete it. The LSITA is completed by patient and caregiver separately.
次要结局
- The General Anxiety Disorder 7-item (GAD-7)(Change from Baseline GAD-7 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
- Patient Health Questionnaire-9 Items (PHQ-9)(Change from Baseline PHQ-9 at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
- Relationship Assessment Scale (RAS)(Change from Baseline RAS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
- Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale](Change from Baseline ADCS-MCI-ADL at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
- Caregiving Outcomes Scale (COS)(Change from Baseline COS at 10 days post-intervention evaluation, 3 months post-intervention, and 6 months post-intervention)
- Patient Health Questionnaire-9 Items (PHQ-9)(Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation)
- The General Anxiety Disorder 7-item (GAD-7)(Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation)
- Alzheimer Disease Cooperative Study MCI-Activities of Daily Living Inventory [ADCS-MCI-ADL Scale](Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation)
- Relationship Assessment Scale (RAS)(Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation)
- Caregiving Outcomes Scale (COS)(Baseline evaluation, 10 days post-12-week-intervention evaluation, 3 months post-12-week-intervention evaluation, and 6 months post-12-week-intervention evaluation)