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Viamigo for People With Dementia and Their Informal Caregivers

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05648864
Enrollment
48
Registered
2022-12-13
Start date
2023-02-07
Completion date
2024-10-31
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

Keywords

social participation, community, technology, mobile application, feasibility

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. Main study parameters/endpoints: 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. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: People with dementia will be asked to fill in the same two questionnaires (approximately 20 minutes in total) during the baseline and post-intervention assessment. Additionally, they are asked to fill in a daily travel diary for one week at baseline and during the last week of the intervention period. Informal caregivers will be asked to fill in the same three questionnaires (approximately 25 minutes in total) during the baseline and post-intervention assessment, and another 15-minutes questionnaire during the post-intervention assessment. Additionally, a smaller sample of the dyads (10 dyads) will be asked to share their experiences using the Viamigo intervention in a semi-structured post-intervention interview of approximately 30 minutes. Dyads will be asked whether they prefer to conduct the different assessments at home or at another location (e.g. Maastricht University). By participating in the study, a participant with dementia might be more often exposed to potentially risky situations in his or her living environment (e.g. traffic). Participation in a technological intervention study can be time-consuming and demanding. One way to reduce the burden of the study is to give participants the freedom to use the Viamigo application at their own pace.

Interventions

DEVICEViamigo

Mobile application with the aim to enhance the independent outdoor mobility of the user while a coach (informal caregiver) can monitor the route from a distance.

Sponsors

Maastricht University Medical Center
Lead SponsorOTHER

Study design

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

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Data collection methods of Viamigo intervention3 monthsNotes 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
Social validity of Viamigo intervention3 monthsmeasured by selfreported Program Participation Questionnaire (PPQ)
Practicality of Viamigo intervention3 monthsPractical constraints in the context and environment to implement the Viamigo intervention (e.g. time or resource availability) will be tracked with notes
Adaptability of Viamigo intervention3 monthsAspects 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
Overall feasibility of Viamigo intervention3 monthsSemi-structured interviews with dyads (participants with dementia and informal caregivers)
Recruitment and drop-out rates3 monthsNumber 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
Recruitment time3 monthsAmount of spent time on recruiting participants (recruitment capability) in weeks

Secondary

MeasureTime frameDescription
Change in out-of-home mobility of participants with dementia at 3 months3 monthsMeasured by a travel diary
Change in social participation of participants with dementia at 3 months3 monthsMeasured by the Engagement and Independence in Dementia Questionnaire (EID-Q), the Lubben Social Network Scale - 6 (LSNS-6), and the post-intervention semi-structured interview
Change in quality of life of informal caregivers at 3 months3 monthsMeasured by the Investigating Choice Experiments CAPability measure for Older people (ICECAP-O)
Change in caregiver burden at 3 months3 monthsMeasured by the Burden Scale for Family Caregivers - short version (BSFC-s)
Change in gains in dementia caregiving at 3 months3 monthsMeasured by Gain in Alzheimer care INstrument (GAIN)

Other

MeasureTime frameDescription
Stage of dementiaweek 0 (baseline)Measured by the Clinical Dementia Rating (CDR)

Countries

Netherlands

Contacts

Primary ContactPascale Heins, MSc
p.heins@maastrichtuniversity.nl0031433881022

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026