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临床试验/NCT03741543
NCT03741543已完成不适用

Learning and Coping With Dementia - User Experiences From an Educative Intervention in Early Stage Dementia

Helse Stavanger HF0 个研究点目标入组 108 人开始时间: 2014年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
108
主要终点
The users experiences from an educative intervention in early-stage dementia

研究概览

简要总结

The overall aim of this study is to investigate how home dwelling people with early-stage dementia cope with their disease, explored through their participation in a 12-week health promotion course, through 3 sub-studies; 1) The users' experience in gaining information about dementia and meeting others in the same situation, 2) observation of the group interactions and support processes, and 3) investigate the effect of the 12-week health promotion course for people with early stage dementia on their cognitive function, psychosocial function and health behaviour.

详细描述

In this study, the investigators build on a health promotion intervention originally developed by Buettner and Fitzimmons (2009), called "Health Promotion for the Mind, Body, and Spirit". The Health Promotion intervention consists of 12 weekly 2-hour sessions. Each group has up to 6 participants, and the groups are facilitated by two professional group leaders. The course has been designed to provide information on the disease process and on healthy behaviours to prevent problems that are common later in the disease. The 12-week course includes nutrition, cognitive fitness, stress reduction, communication, information about the course of the disease, and coping strategies. During the first class session, each participant received a nametag and a booklet. This booklet is a critical component of the educational method for the participants. The booklet contains 12 dividers for the 12 modules that the instructor taught during the course. The caregiver is not present at the course, however the participants are encouraged to share the booklet provided at the course with the caregiver between sessions.

Design: a quasi-experimental study with multiple methods:

  1. assessment of cognitive function, psychosocial function and health behaviour is collected at baseline (prior to attending the 12-week course) and follow-up interviews are arranged shortly after the 12-week course. For each participant a caregiver also has to take part for proxy interviews.
  2. the users' experience of attending the 12-week health promotion course will be collected through qualitative individual interviews with the participants and their caregiver after attending the course.
  3. over the duration of the course a moderate participant observation will be carried out to explore changes over the 12-week course, in-session behaviour, social interaction and to capture motivational and empowering aspects of the course.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years of age or older
  • A diagnosis of early or moderate stage dementia
  • Capable of reading and writing
  • Hearing and vision which are sufficiently good to work in a group setting
  • Proficient in the language in which the course is provided

排除标准

  • A diagnosis of alcohol abuse
  • A limited life expectancy due to any terminal disease or other serious illness
  • Chemotherapy or radiation treatment ongoing at enrolment
  • Head injuries
  • Parkinson's disease
  • A history of psychiatric illness
  • A history of a diagnosis of subnormal intelligence
  • Prior participation in health promotion or cognitive training programs

研究组 & 干预措施

A 12-week health promotion course

Other

The Health Promotion intervention consists of 12 weekly 2-hour sessions with a group of up to six participants and two course facilitators. Teaching methods includes lecture, questions- and answer periods, and interactive hands-on learning. During the class sessions, the facilitators encourages the participants to ask questions and make comments about the lecture at any time. During the first class session, each participant receives a booklet with the course material

干预措施: A 12-week health promotion course (Other)

结局指标

主要结局

The users experiences from an educative intervention in early-stage dementia

时间窗: Baseline, 3 months

Qualitative data will be collected through semi-structured individual interviews with both participants and their caregiver (proxy), and through moderate participant observations following the participants over the duration of the 12-week course. The interview guide and observational protocol consist of pre-selected topics, including (1) communication, (2) participant engagement, (3) social interaction within the group, (4) peer support (5) change in perception of living with dementia and (6) educational outcome. The qualitative data will be explored using content analysis.

次要结局

  • Change in managing personal activities of daily life(Baseline, 3 months)
  • Change in managing instrumental activities of daily life(Baseline, 3 months)
  • Change in neuropsychiatric symptoms(Baseline, 3 months)
  • Change in carer stress/burden(Baseline, 3 months)
  • Change in cognitive function(Baseline, 3 months)
  • Change in self-rated health(Baseline, 3 months)
  • Change in depressive symptoms(Baseline, 3 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

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