跳至主要内容
临床试验/NCT05648864
NCT05648864招募中不适用

Geographic Information System (GIS) Based Intervention 'Viamigo' for People With Dementia and Their Informal Caregivers: A Single-arm Trial to Evaluate the Feasibility and Preliminary Participant Responses

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年2月7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
48
试验地点
2
主要终点
Overall feasibility of Viamigo intervention

研究概览

简要总结

The main objective of this study is to evaluate the feasibility of the Geographic Information System (GIS)-based mobile application 'Viamigo' among people with dementia living in the community and their informal caregivers. Viamigo aims to support the independent out-of-home mobility of the user and to reduce informal caregiver's burden by teaching users a known individual route, which they can accomplish independently while being monitored by an informal caregiver. Although Viamigo was initially developed for persons with intellectual disabilities, it is expected that it can also support and improve out-of-home mobility and thereby the social participation of people with dementia. The design of the study is a mixed methods single-arm pre-post design with a baseline assessment, a 3-month intervention period, and a post-intervention assessment. Dyads (n=24) of people with mild to moderate dementia living in the community and their informal caregivers will use the mobile application for 3 months. The main study parameter is the feasibility of the Viamigo intervention for people with dementia and their informal caregivers. Secondary study parameters for people with dementia include out-of-home mobility and social participation. Secondary study parameters for informal caregivers include quality of life, caregiver burden, and gains in dementia caregiving.

详细描述

Rationale: People with dementia living in the community experience reduced out-of-home mobility and participate less in activities outside the home. This results in reduced social participation outside the home, which can negatively affect their health (e.g. leads to social isolation and increased risk of depressive symptoms). Technological interventions show promise in enhancing the social participation of people with dementia. However, there is a lack of technological interventions that facilitate social participation outside the home. While a growing body of evidence highlights the potential of Geographic Information Systems (GIS) in facilitating the out-of-home mobility of people with dementia and reducing informal caregivers' feelings of worry, very little attention is paid to the potential of GIS in enhancing the social participation of people with dementia. The GIS-based mobile application Viamigo aims to support the independent out-of-home mobility of the user and to reduce informal caregiver's burden by teaching users a known individual route, which they can accomplish independently afterwards while being monitored by an informal caregiver. Although Viamigo was initially developed for persons with intellectual disabilities, it is expected that it can also support and improve out-of-home mobility and thereby the social participation of people with dementia.

Objective: The main objective of this study is to evaluate the feasibility of the Viamigo intervention among people with dementia living in the community and their informal caregivers. The secondary objective of this study is to assess the first responses of people with dementia and informal caregivers to the Viamigo intervention.

Study design: This feasibility study includes a mixed methods single-arm pre-post design with a baseline assessment, a 3-month intervention period, and a post-intervention assessment.

Study population: The study population consists of dyads (n=24) of people with mild to moderate dementia living in the community and their informal caregivers. There are no restrictions regarding sex, educational level, or cultural background.

Intervention (if applicable): All eligible and consenting dyads will be asked to participate in the Viamigo intervention, consisting of three main components: (1) a face-to-face technology training session of 60 minutes, (2) a 3-month period of using the Viamigo intervention with support phone calls of approximately 5 minutes by the coordinating investigator once every two weeks, and (3) an evaluation phone call of 5-10 minutes.

研究设计

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

盲法说明

dyads of people living with dementia (n=24) and their informal caregivers (n=24)

入排标准

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

入选标准

  • 未提供

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • No informed consent given;
  • Concurrent participation in any other interventional study.

结局指标

主要结局

Overall feasibility of Viamigo intervention

时间窗: 3 months

Semi-structured interviews with dyads (participants with dementia and informal caregivers)

Social validity of Viamigo intervention

时间窗: 3 months

measured by selfreported Program Participation Questionnaire (PPQ)

Recruitment time

时间窗: 3 months

Amount of spent time on recruiting participants (recruitment capability) in weeks

Practicality of Viamigo intervention

时间窗: 3 months

Practical constraints in the context and environment to implement the Viamigo intervention (e.g. time or resource availability) will be tracked with notes

Data collection methods of Viamigo intervention

时间窗: 3 months

Notes on: if outcome measures were sensitive to change; how understandable data collection procedures were for study participants; and how much time was required to fill in questionnaires

Recruitment and drop-out rates

时间窗: 3 months

Number of referred dyads, number of eligible participants who are willing to participate, number of eligible participants who are not willing to participate, including reasons for declined participation (if provided); number of dropouts during the baseline assessment (after signing informed consent and before starting the intervention) as well as reasons for dropout, if provided; number of dropouts after starting the intervention and reasons for dropout, if provided

Adaptability of Viamigo intervention

时间窗: 3 months

Aspects facilitating or impeding the flexibility of the intervention, as well as a potential needed set of requirements to implement the intervention with people with dementia and their informal caregivers will be tracked with notes

次要结局

  • Change in out-of-home mobility of participants with dementia at 3 months(3 months)
  • Change in social participation of participants with dementia at 3 months(3 months)
  • Change in quality of life of informal caregivers at 3 months(3 months)
  • Change in caregiver burden at 3 months(3 months)
  • Change in gains in dementia caregiving at 3 months(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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