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DementiaNCT05648864

Viamigo for People With Dementia and Their Informal Caregivers

A study testing Viamigo in people with Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dementia
What is being tested?
Viamigo
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteNetherlands
Study dates
7 Feb 2023to Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • Maastricht University

    Maastricht, 6229 ET

    Pascale Heins, MSc, 0031433881022, p.heins@maastrichtuniversity.nl

    Marjolein E de Vugt, Prof

    Recruiting

Other trials in Netherlands

About this study

Official title: 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

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.

Read the 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.

Conditions
Dementia
Being tested
Viamigo
Keywords
social participation, community, technology, mobile application, feasibility
Medical subject headings
Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ViamigoDevice

    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.

Study groups in NCT05648864
Study groupRoleWhat they receive
Viamigo interventionExperimentalAll 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.
Receives: Device: Viamigo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall feasibility of Viamigo intervention

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

    Measured: 3 months

  2. Recruitment and drop-out rates

    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

    Measured: 3 months

  3. Recruitment time

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

    Measured: 3 months

  4. Data collection methods of Viamigo intervention

    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

    Measured: 3 months

  5. Social validity of Viamigo intervention

    measured by selfreported Program Participation Questionnaire (PPQ)

    Measured: 3 months

  6. Practicality of Viamigo intervention

    Practical constraints in the context and environment to implement the Viamigo intervention (e.g.

    time or resource availability) will be tracked with notes

    Measured: 3 months

  7. Adaptability of Viamigo intervention

    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

    Measured: 3 months

Secondary outcomes (5)
  1. Change in out-of-home mobility of participants with dementia at 3 months

    Measured by a travel diary

    Measured: 3 months

  2. Change in social participation of participants with dementia at 3 months

    Measured 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

    Measured: 3 months

  3. Change in quality of life of informal caregivers at 3 months

    Measured by the Investigating Choice Experiments CAPability measure for Older people (ICECAP-O)

    Measured: 3 months

  4. Change in caregiver burden at 3 months

    Measured by the Burden Scale for Family Caregivers - short version (BSFC-s)

    Measured: 3 months

  5. Change in gains in dementia caregiving at 3 months

    Measured by Gain in Alzheimer care INstrument (GAIN)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2022
  2. Study start7 Feb 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05648864
Sponsor's protocol ID
NL81938.068.22
Status last verified
Nov 2023
First submitted
5 Oct 2022
Last updated
22 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After completion of the study, an anonymised version of the data will be made available for reuse on a data repository, such as Dataverse.nl. No personal data will be included. Access to this data will be allowed under specified conditions (still in discussion with the legal advisor of Maastricht University). All participants will be asked for consent to reuse their data.

Questions about this trial

What is this clinical trial studying?

A study testing Viamigo in people with Dementia, run by Maastricht University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pascale Heins, MSc (0031433881022, p.heins@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall feasibility of Viamigo intervention (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.

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