Extending Independence and Quality of Life for People With Alzheimer's Disease or Dementia Through Telehealth Program Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
研究概览
简要总结
To determine whether Moving Together improves quality of life in people with memory loss (PWML) and caregivers (CG) by performing a randomized, controlled trial (RCT) with a waitlist control group in 224 dyads.
详细描述
The investigators will perform an RCT with a 12-week delayed start control group in 224 dyads of PWMLs and CGs. The primary outcome in PWML will be self-rated quality of life (Quality of Life in Alzheimer's Disease, QOL-AD). Secondary outcomes will include: a) self-reported emotional well-being; b) self-reported social isolation; c) self-reported mobility; and d) directly assess cognitive performance. In CGs, the primary outcome will be self-rated quality of life (SF-12). Secondary outcomes in CGs will include: a) healthy days; b) self-efficacy; c) burden; d) social isolation; e) ability to self-regulate; f) positive affect; and g) sleep quality. In addition, the investigators will ask CGs to report sleep quality, mobility, and cognitive function for PWML. Additional exploratory outcomes will include health services utilization (hospitalizations, emergency department visits) and falls.
In addition to the RCT, the investigators propose to compare health utilization outcomes in study participants to a matched 'no contact' comparison sample of patients with dementia diagnoses who receive care in the University of California San Francisco (UCSF) Health system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Dyads will be enrolled and randomized in blocks of 16 (n=8 immediate start, n=8 waitlist). The randomization sequence will be generated in advance by Dr. Barnes' team using a random number generator and will be maintained in a secure location. Individuals who collect or analyze outcome data will be unaware of the randomization sequence and blinded to group assignment.
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
- •People with memory loss (PWML):
- •U.S. resident;
- •English language fluency;
- •diagnosis of Alzheimer's disease or other dementia; mild severity, assessed using the Quick Dementia Rating System.
- •Caregivers (CG):
- •U.S. resident;
- •English language fluency;
- •Primary caregiver for PWML;
- •own one or more devices that can be used to participate in two-way livestreaming video classes (e.g., smart phone/tablet + TV, laptop or desktop with webcam, smart TV);
- •willing and able to participate in two-way livestreaming group movement classes with person with PWML.
排除标准
- •Age < 18 years;
- •primarily use wheelchair inside home;
- •limited life expectancy (e.g., enrolled in hospice, meta-static cancer);
- •physical limitations that could affect ability to participate (e.g., difficulty sitting for 1 hour, chronic pain, vertigo);
- •severe visual impairment (e.g., unable to observe instructor's movements on screen);
- •severe hearing impairment (e.g., unable to hear instructor's requests);
- •behavioral or psychiatric issues that could be disruptive in group setting (e.g., history of physical or verbal abuse, schizophrenia, bipolar disorder, substance abuse);
- •unable to provide consent/assent;
- •planning to travel for >1 week during initial 12-week study period.
结局指标
主要结局
Quality of Life - Change (Quality of Life in Alzheimer's Disease Scale, QOL-AD)
时间窗: Baseline to 12-weeks
The QOL-AD is a standard quality of life measure that has been validated for people with cognitive impairment. Scores may range from 0-52, with higher scores reflecting better quality of life.
Caregiver Physical Health - Change (Short Form Health Survey [SF-12] Physical Composite Score [PCS])
时间窗: Baseline to 12-weeks
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
Caregiver Mental Health - Change (Short Form - 12 [SF-12] Mental Composite Score [MCS])
时间窗: Baseline to 12 weeks
The Short Form Health Survey (SF-12) is a 12-item questionnaire that was developed as a shorter alternative to the SF-36 Health Survey (SF-36). It consists of a subset of 12 items from the SF-36 covering the same eight domains of health outcomes and generates two summary scores: the Physical and Mental Health Composite Scores (PCS, MCS). Scores may range from 0-100, with higher scores reflecting better levels of health.
次要结局
- Caregiver Positive Affect (Positive States of Mind)(Baseline to 12-weeks)
- Well-being - Change (Neuro-QOL v1.0 Positive Affect and Well-Being Short Form)(Baseline to 12-weeks)
- Social Isolation - Change (Patient-Reported Outcomes Measurement Information System v2.0 Social Isolation Scale)(Baseline to 12-weeks)
- People With Memory Loss (PWML) Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)(Baseline to 12-weeks)
- People With Memory Loss (PWML) Cognitive Function - Change (Cognitive Function Instrument - Modified)(Baseline to 12-weeks)
- Mobility - Change (Neuro-QOL Short Form V1.0 - Lower Extremity Function - Mobility)(Baseline to 12-weeks)
- Cognitive Function - Change (Telephone Montreal Cognitive Assessment, t-MoCA)(Baseline to 12-weeks)
- Caregiver Healthy Days - Change (Healthy Days Core Module)(Baseline to 12-weeks)
- Caregiver Self-efficacy - Change (Gain in Alzheimer Care INstrument (GAIN))(Baseline to 12-weeks)
- Caregiver Burden - Change (Zarit Burden Interview, 6-item Version)(Baseline to 12-weeks)
- Caregiver Social Isolation - Change (PROMIS v2.0 Social Isolation Scale)(Baseline to 12-weeks)
- Caregiver Self-regulation - Change (Abbreviated Multidimensional Assessment of Interoceptive Awareness-2 (MAIA) Self-regulation Subscale)(Change from baseline to 12-weeks)
- Caregiver Sleep - Change (Symptom Checklist, 3 Items)(Baseline to 12-weeks)
- People With Memory Loss (PWML) Sleep - Change (Symptom Checklist, 3 Items)(Baseline to 12-weeks)