Skip to main content
Clinical Trials/NCT05648864
NCT05648864UnknownNot Applicable

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 Center1 site in 1 country48 target enrollmentStarted: February 7, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
48
Locations
1
Primary Endpoint
Practicality of Viamigo intervention

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

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

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •people with dementia:
  • •Capacity to give informed consent;
  • •Diagnosis of mild to moderate dementia as evaluated by a healthcare professional and as reported by the person with dementia and the informal caregiver (by asking when and where the person has been diagnosed and by who);
  • •Living in the community (alone or with family/roommate(s)/friends);
  • •Taking part in social activities outside the home;
  • •Availability of an informal caregiver who is interested to take part in this study;
  • •Having an Android smartphone, as the Viamigo application to be used by the person with dementia is currently exclusively available for Android.
  • •Inclusion criteria informal caregivers:
  • •Family caregiver of participant diagnosed with mild to moderate dementia;
  • •Aged 18+;
  • •Having at least weekly contact with the person with dementia;
  • •Having an Android or Apple smartphone and laptop/computer.

Exclusion Criteria

  • •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.

Arms & Interventions

Viamigo intervention

Experimental

All eligible and consenting dyads will be asked to participate in the Viamigo intervention (mobile application), 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.

Intervention: Viamigo (Device)

Outcomes

Primary Outcomes

Practicality of Viamigo intervention

Time Frame: 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

Overall feasibility of Viamigo intervention

Time Frame: 3 months

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

Social validity of Viamigo intervention

Time Frame: 3 months

measured by selfreported Program Participation Questionnaire (PPQ)

Recruitment time

Time Frame: 3 months

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

Data collection methods of Viamigo intervention

Time Frame: 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

Time Frame: 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

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials