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.
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
- Recruiting
Maastricht University
Maastricht, 6229 ET
Pascale Heins, MSc, 0031433881022, p.heins@maastrichtuniversity.nl
Marjolein E de Vugt, Prof
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Viamigo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall feasibility of Viamigo intervention
Semi-structured interviews with dyads (participants with dementia and informal caregivers)
Measured: 3 months
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
Recruitment time
Amount of spent time on recruiting participants (recruitment capability) in weeks
Measured: 3 months
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
Social validity of Viamigo intervention
measured by selfreported Program Participation Questionnaire (PPQ)
Measured: 3 months
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
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)
Change in out-of-home mobility of participants with dementia at 3 months
Measured by a travel diary
Measured: 3 months
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
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
Change in caregiver burden at 3 months
Measured by the Burden Scale for Family Caregivers - short version (BSFC-s)
Measured: 3 months
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.
- First posted13 Dec 2022
- Study start7 Feb 2023
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marjolein E. de Vugt, Prof., Principal investigator, Maastricht University
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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05648864
- Acronym / sponsor ID
- NL81938.068.22
- Conditions
- Dementia
- Keywords
- social participation, community, technology, mobile application, feasibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Viamigo intervention | Experimental | Device: ViamigoAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViamigoMobile 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. | Device | Viamigo intervention |
Primary outcome
Overall feasibility of Viamigo intervention
Time frame: 3 months
Semi-structured interviews with dyads (participants with dementia and informal caregivers)
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
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
Social validity of Viamigo intervention
Time frame: 3 months
measured by selfreported Program Participation Questionnaire (PPQ)
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
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
5 secondary outcomes
Change in out-of-home mobility of participants with dementia at 3 months
Time frame: 3 months
Change in social participation of participants with dementia at 3 months
Time frame: 3 months
Change in quality of life of informal caregivers at 3 months
Time frame: 3 months
Change in caregiver burden at 3 months
Time frame: 3 months
Change in gains in dementia caregiving at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjolein E. de Vugt, Prof. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
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.