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临床试验/NCT05920733
NCT05920733招募中不适用

Healthy Lifetime - Sustainability and Quality Study - PHASE 2

University of Michigan2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
Change in Participant Self- rated health score

研究概览

简要总结

HealthyLifetime (HL) is a person-centered program that enables older adults to maximize health and optimize functioning - the necessary requisite to successfully remaining independent in their preferred home setting as long as possible, i.e., to age in place.

详细描述

HL seeks to intervene early in the aging process when individuals have the best chance for longer term benefits of changing their health behavior, as a means to stave off functional decline, and minimize the onset or exacerbation of chronic conditions. And, for individuals who are experiencing any of the barriers described above, our HL program's Nurse Coaches are prepared and experienced in helping them achieve their highest level of functioning and self-care capacity, while integrating and collaborating with, but not duplicating, their medical services such as primary care, specialty care, and case management or medical social services. While the latter medically oriented services support clinical management, they do not focus on helping older adults maximize health and function by building self-care capacity, long term health behavior change capacity and the functional resilience necessary to sustain or regain independent living.

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
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Be able to read, speak English and hear - but may use glasses or hearing aids, if needed;
  • Be able to tell us their age, their date of birth, address, and phone number, as well as write down and explain their health problems;
  • Have their own computer or iPad (Tablet) with an Internet connection, a working camera and microphone. and
  • Be able to use their computer/tablet to connect to video chat sessions like Zoom in a private space in their home or a private room.

排除标准

  • People who, in the last month, have used the Emergency Room (ER) or stayed in the hospital.
  • Are not verified users of Medicaid Home Help services [we will check with the Michigan Department of Health and Human Service to verify that you receive these services using your name, date of birth, and Medicaid identification number];
  • Have a new major health problem that they are seeing a doctor about more than once per month;
  • Have been told their illness is not curable;
  • Cannot remember their name, date of birth or their health problems;
  • Cannot use glasses or a hearing aid to see or hear well enough to read materials on the computer or talk to the nurse easily; and,
  • Do not have, or cannot use, a computer, iPad or other device with the Internet at home to use Zoom (e.g., internet streaming).

结局指标

主要结局

Change in Participant Self- rated health score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Participants perception of their health on a scale of 1= Excellent to 5 = Poor

Change in Food Consumption

时间窗: At 0, 8 and 20 weeks after study enrollment.

Participants report how frequently they eat foods from different food groups, e.g., vegetables, fruits, grains, dairy, sugary, etc.

Change in Vigorous Activity

时间窗: At 0, 8 and 20 weeks after study enrollment.

Number of days out of the past seven did participants do vigorous or moderate activities at work, as part of their house and yard work, to get from place to place, and in their spare time for recreation, exercise, or sport.

Change in Independent self-care agency score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Confidence in doing certain activities, e.g., stick to behavior changes, meet goals, and improve health, on a scale of 1= Not at all confident to 10 = Totally Confident

Change in Goal attainment score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Health goals (up to 3) of participants and importance of goal (1= Not at all important now to 10 = highest importance now) and confidence in achieving goal (1= Not confident at all to 10 = Completely Confident)

Change in Level of Symptomatology score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Frequency with which participants experience symptoms such as physical discomfort, pain, fatigue, etc. on a scale where 0 = Never to 5 = Always

Change in Health Habits score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Activities that participants engage in that affect health in a negative or positive way, e.g., smoking (yes or no), alcohol (number of drinks per week), exercise (0 = none to 4= more than 3 hours/week), food choices (seldom or never to 2 or more times a day)

Change in Quality of Life score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Questions about how participant experiences their quality of life. Covers six areas and includes how satisfied they are with these areas, and how important they are to them. Uses a scale where "0" = "Do not agree at all" and "4" = "Agree completely"

Change in Exercise and Activities

时间窗: At 0, 8 and 20 weeks after study enrollment.

DURING THE PAST 7 DAYS, even if it was not a typical week for participants, how much total time (for the entire week) did they spend on each of various exercises or activities, e.g., walking, swimming, bicycling, etc.

Change in Self-efficacy in ability to continue essential life activities score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Confidence of the participant in doing certain activities on a scale of 1= Not at all confident to 10 = Totally Confident. For the purposes of answering these questions, confidence is defined as the belief in the participant's chances of being able to do and/or complete an activity (e.g., hobbies and recreation, social visits, chores, errands, etc.) or task (e.g., hobbies and recreation, social visits, chores, errands, etc.) successfully however the participant defines it.

Change in Lifestyle Habits

时间窗: At 0, 8 and 20 weeks after study enrollment.

Questions about tobacco and alcohol use: Do participants use alcohol and/or tobacco, and, if so, how much

Change in Level of independence in household activities score

时间窗: At 0, 8 and 20 weeks after study enrollment.

Ability to do daily living activities such as shopping, cooking, managing medications, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident

Change in Confidence in ability to manage symptoms score

时间窗: At 0, 8 and 20 weeks after study enrollment.

How confident the is participant that they can keep health symptoms/problems from interfering with the things they want to do, e.g., fatigue, physical discomfort, emotional distress, etc. on a scale where 1 = Not at all Confident to 10 = Totally Confident

Change in Other Symptoms

时间窗: At 0, 8 and 20 weeks after study enrollment.

Questions ask how often a participant is bothered by psychological and emotional symptoms such as feeling nervous, worry, anxiety, sadness, etc. On a scale from 0 Not at All to 3 Nearly Every Day.

Change in Health Impact

时间窗: At 0, 8 and 20 weeks after study enrollment.

Using a "1" to "10" scale where "1" = "Almost never" and "10" = "Almost totally", participant selects ONE number which best represents how much their health impacts their ability to do or participate in an activity AT THE PRESENT TIME.

次要结局

  • Change in Self-reported medical visits(At 0, 8 and 20 weeks after study enrollment.)
  • Change in type and source of At-home Support(At 0, 8 and 20 weeks after study enrollment.)
  • Change in Social Network and Support score(At 0, 8 and 20 weeks after study enrollment.)
  • Higher values of primary measures at 8 weeks: persistence at 20 weeks(20 weeks after study enrollment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Potempa

Professor

University of Michigan

研究点 (2)

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