Viamigo for People With Dementia and Their Informal Caregivers

NCT05648864 | Unknown DMC

• 1 other identifier: NL81938.068.22
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

social participation; community; technology; mobile application; feasibility

Outcome Measures

Primary Outcomes (7)

• Overall feasibility of Viamigo intervention

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

  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

  3 months

• Recruitment time

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

  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

  3 months

• Social validity of Viamigo intervention

  measured by selfreported Program Participation Questionnaire (PPQ)

  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

  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

  3 months

Secondary Outcomes (5)

• 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

Other Outcomes (1)

• Stage of dementia

  week 0 (baseline)

Study Arms (1)

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.

Device: Viamigo

Interventions

Viamigo DEVICE

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.

Viamigo intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, 6229 ET, Netherlands

RECRUITING

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marjolein E. de Vugt, Prof.

  Maastricht University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascale Heins, MSc

CONTACT

0031433881022; p.heins@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: dyads of people living with dementia (n=24) and their informal caregivers (n=24)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: December 13, 2022
• Study Start: February 7, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 22, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Anonymised data will become available right after the completion of the study. All data will be securely stored and available for 15 years after the last publication on the data.
• Access Criteria: Access to the data collection will be restricted by conditions for use. These conditions will be determined in consultation with a legal adviser of Maastricht University. The legal adviser has been contacted via e-mail (privacy@maastrichtuniversity.nl).

Locations

NL (1)