Piloting the IPROACTIF Program to Preserve Functioning and Prevent Cognitive Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Physical Functioning Measured Using the Patient-Specific Functional Scale
研究概览
简要总结
Conduct a pilot randomized control to assess the preliminary efficacy of IPROACTIF, an occupational therapist-delivered primary care intervention for aging and chronic disease management.
详细描述
The IPROACTIF intervention is based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease. The 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning. This pilot randomized control trial will compare whether patients who receive IPROACTIF perform better than usual care patients on physical functioning, self-efficacy for chronic disease management, physical activity levels, executive functioning, health-related quality of life, and participation in life roles and activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The statistician conducting data analysis will be blinded to group assignment of study participants. A numerical code will be used to identify the study arm for each participant in the outcome database. Outcome measurement will be carried out by blinded assessors at baseline and immediately post-intervention.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Community-dwelling
- •55 years of age
- •Primary diagnosis of heart disease (coronary artery disease, ischemic heart disease, hypertensive heart disease), or uncontrolled diabetes (HBA1c greater than/equal to 10)
- •Self-reported risk of functional decline (score of 3 or higher) on the 11-item Brief Risk Identification of Geriatric Health Tool or self-reported need for assistance with disease management
排除标准
- •Current/past diagnosis of stroke or other neurological disorders
- •Receiving pharmacological treatment for cognition
- •Participating in other exercise or ADL-focused intervention studies
- •Non-English speaking
- •Residing in a long-term care institution
- •Compromised decision-making capacity (score >8 on SOMCT)
研究组 & 干预措施
IPROACTIF
10 weekly sessions. First two sessions focus on comprehensive assessment of physical and executive functioning, assessment of home safety and accessibility, assessment of ADL/IADL competence and performance in context; information in these areas is used by the interventionist to collaboratively identify three patient-centered goals. Goal planning is followed by 10 treatment sessions. Treatment sessions focus on chronic disease education, problem solving issues related to disease management by modifying daily routines, recommendations for embedding physical activity in everyday tasks, and environmental modifications or activity adaptations to increase ADL/IADL independence.
干预措施: IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) (Other)
Usual care
Participants in the control group will receive usual services which might include primary care and prescription medications for chronic disease management.
干预措施: Usual primary care services (Other)
结局指标
主要结局
Physical Functioning Measured Using the Patient-Specific Functional Scale
时间窗: 12 weeks
Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20
时间窗: 12 weeks
The PROMIS Physical Function Short Form 20 (PF-20) is a measure of perceived ability to perform physical activities. Respondents rate 20 daily activities on a scale from 1 (unable to do) to 5 (no difficulty/limitation). Individual item scores are summed to compute the total raw score which is converted to a standardized T-score. T-scores range from 9.2 to 62.7. Higher T-scores indicate a better outcome. A score of 50 is the average for the United States general population with a standard deviation of 10.
Physical Functioning Measured Using the Physical Performance Test (9-item)
时间窗: 12 weeks
9-item performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 2.4 points
Physical Functioning Measured Using the Patient-Specific Functional Scale
时间窗: 12 weeks
Validated self-reported assessment; respondent identifies up to 5 important activities they are experiencing difficulty with. Total score = sum of the activity scores/number of activities. scoring Scores can range from 0 to 10; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 1.2-2.2 points
Physical Functioning Measured Using the PROMIS Physical Function Short Form 20
时间窗: 12 weeks
The PROMIS Physical Function Short Form 20 (PF-20) is a measure of perceived ability to perform physical activities. Respondents rate 20 daily activities on a scale from 1 (unable to do) to 5 (no difficulty/limitation). Individual item scores are summed to compute the total raw score which is converted to a standardized T-score. T-scores range from 9.2 to 62.7. Higher T-scores indicate a better outcome. A score of 50 is the average for the United States general population with a standard deviation of 10.
Physical Functioning Measured Using the Physical Performance Test (9-item)
时间窗: 12 weeks
9-item performance-based assessment; scores can range from 0 to 36; higher scores indicate better physical functioning Minimal clinically important difference in previous studies = 2.4 points
次要结局
- Executive Functioning Using the Executive Function Performance Test(12 weeks)
- Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center(12 weeks)
- Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension(12 weeks)
- Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension(12 weeks)
- Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)(12 weeks)
- Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)(12 weeks)
- Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center(12 weeks)
- Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills(12 weeks)
- Executive Functioning Using the Dimensional Change Card Sort Test(12 weeks)
- Physical Activity Level(12 weeks)
- Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Frequency Dimension(12 weeks)
- Participation in Life Activities and Roles Using the Late Life Functioning and Disability Index (Disability Component) - Limitations Dimension(12 weeks)
- Health Related Quality of Life Using the PROMIS Global Health Measure (Physical Subscale)(12 weeks)
- Health Related Quality of Life Using the PROMIS Global Health Measure (Mental Subscale)(12 weeks)
- Self-efficacy Measured Using the Doing Chores Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy Measured Using the Manage Symptoms Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy for Chronic Disease Management Using the Obtain Help From Community, Family, Friends Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy for Chronic Disease Management Using the Manage Disease in General Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy for Chronic Disease Management Using the Social Recreational Activities Scale From the Self-Management Resource Center(12 weeks)
- Self-efficacy for Chronic Disease Management Using the Exercise Regularly Scale From the Self-Management Resource Center(12 weeks)
- Performance of Daily Living Tasks Using the Performance Assessment of Self-care Skills(12 weeks)
- Executive Functioning Using the Executive Function Performance Test(12 weeks)
- Executive Functioning Using the Dimensional Change Card Sort Test(12 weeks)
- Physical Activity Level(12 weeks)
研究者
Mansha Parven Mirza
Assoc Professor
University of Illinois at Chicago