Memory ProblemsCOORDINATEsNCT04267484
What Are my Options to Stay Safe at Home: Technology For Aging at Home
An observational study of Memory Problems and Aging, run by CHU de Quebec-Universite Laval at 4 sites in 3 countries.
Trial summary
Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Memory Problems, Aging, Mild Cognitive Impairment
- What is being tested?
- GPS and travel diary and e-decision support platform
- Type of treatment
- Medical device
- How many people
- 294 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 28 Nov 2018to Nov 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly (>65 years) with mild cognitive impairment or self reported memory problems.
Who may be able to join
- Aged ≥ 65 years
- Living at home
- Diagnosed with mild cognitive impairment or experiencing memory issues
- Able to read, understand and write
- Can provide informed consent
Who cannot join
- Older adults who are not able to provide informed consent
- Living in nursing home or hospital
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton
Allyson Jones
- Recruiting
CERSSPL
Québec, Quebec
France Légaré, MD, PhD
Netherlands1 site, 1 recruiting
- Recruiting
University of Groningen
Groningen
Louise Meijering
About this study
Official title: Technology to Support Decision Making About Aging at Home (COORDINATEs)
Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. New technologies have the potential to provide information about changing patterns that reflect changing care needs. This information could help older adults, caregivers and health professionals to participate in decision-making about housing options when a change in living environment needs to be considered.
Read the detailed description
This is a multi-phase study to be conducted in 3 countries: Canada (Quebec and Alberta), Sweden and Netherlands. The primary objective is to provide e-decision support technology that will facilitate self-management in the context of aging in place and foster informed value congruent decisions about options to age safely at home.
The aim of the project is to develop and validate a e-technology based on already existing components (e.g. GPS devices, diverse e-platforms and decision support interventions) to 1) help older adults with mild cognitive impairment/memory problems to stay safely at home as long as possible and 2) to provide older adults with decision support tools to help them make informed value congruent decisions (e.g. foster a shared decision-making process) regarding aging at home in a safe manner.
The secondary objectives are:
- Assess autonomy and mobility of older adults with mild cognitive impairment/memory problems living at home.
- Inform shared decision-making processes about options to safely age in place for all those involved.
The investigators will apply an integrated Knowledge Translation (iKT), comparative, mixed-methods approach to explore, older adults living at home with mild cognitive impairment/memory problems, their use of space in their homes and neighbourhoods.
The project is divide into 4 work package (WP). In more details, during WP1, the investigators will collect spatial data (e.g. using GPS) and self-reported data (e.g. travel diaries, walking interviews, in-depth interviews, surveys). At WP2, the investigators will use iterative end-user feedback and end-user consultation discussion group to tailor a decision support technology to knowledge-users. At WP3, investigators will assess user opinion regarding factors that could influence their use of the newly adapted e-decision support technology. Finally, at WP4 the investigators will triangulate data and take into account differences between jurisdictions.
This collaboration and our cross-country comparisons will contribute to scaling up e-decision support solutions in the future for the older adults with mild cognitive impairment/memory problems who want to age safely at home.
- Being tested
- GPS and travel diary, e-decision support platform
- Keywords
- Shared decision making, Mild Cognitive Impairment, Technology, aging in place, memory problem
- Medical subject headings
- Memory Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPS and travel diaryDevice
WP1: GPS tracker for 2 weeks and a daily diary about activity (travel diary).
e-decision support platformOther
WP2 and WP3: An e-decision support platform that will foster shared decision making about options to stay safe at home for the older adult.
| Study group | Role | What they receive |
|---|---|---|
| Older adults with mild cognitive impairment | WP1, older adults with cognitive impairment will use a GPS tracker for 2 weeks, during which they are asked 1) to keep a daily diary about their activity (travel diary), 2) take the researcher on a walk that they often do (walking interview), and 3) participate in an in-depth interview after 2 weeks, in which their experience with the GPS ans the travel diary data are discussed.
WP2, older adults with mild cognitive impairment, caregivers, health professionals and technology developers will collaborate during group discussion meeting to co-design the e-decision support platform to be adapted.
WP3, older adults with mild cognitive impairment, caregivers and health professionals will then be asked to use the adapted e-decision support platform and fill a survey. Receives: Device: GPS and travel diary; Other: e-decision support platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomy and mobility assessment using GPS
WP1: 1) Asses autonomy and mobility of older adults with mild cognitive impairment and memory problems living at home (including caregivers), their movement through their homes and neighborhoods (using GPS and walking interview); 2) how GPS data can support ongoing SDM about housing options for older adults.
Measured: Participant will wear a GPS for a total of two weeks. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
Iterative assessment to tailor the e-decision support technology
WP2: 1) Group discussion on if and how to incorporate GPS and adaptation of an existing e-platforms to create an adapted e-decision support technology (noted that the discussion focus will depend on result from WP1).
Measured: Immediately after group discussion. 3 sequential group discussion are plan to occur, one in each country (Canada, Sweden, Netherlands) data collection will happen over a period of 1 year.
User experience assessment of the newly adapted technology
WP3: 1) Opinion of older adults with mild cognitive impairment, caregivers and health professionals about the adapted technology (noted that the final survey will depend on result from WP1 and WP2).
Measured: Immediately after testing the new platform. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands), it will happen over a period of 6 months
Secondary outcomes (2)
Inform SDM processes about housing option
WP4: 1) Knowledge about differences and similarities between three countries
Measured: 9 months
Open-ended questionnaire of participant global health status and their experience of using the GPS and filling the travel diary
WP1: Participant will be ask to share their experience with the GPS and the travel diary
Measured: Immediately before and after carrying the GPS at WP1. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start28 Nov 2018
- Primary completionAug 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Memory ProblemsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Laval University, Dalarna University, University of Groningen, University of Alberta
- Responsible party
- Principal investigator, France Legare, CHU de Quebec-Universite Laval
- Investigators
- France Légaré, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267484
- Sponsor's protocol ID
- 118792
- Acronym
- COORDINATEs
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caron CD, Ducharme F, Griffith J. Deciding on institutionalization for a relative with dementia: the most difficult decision for caregivers. Can J Aging. 2006 Summer;25(2):193-205. doi: 10.1353/cja.2006.0033.
PubMed 16821201Garvelink MM, Emond J, Menear M, Briere N, Freitas A, Boland L, Perez MMB, Blair L, Stacey D, Legare F. Development of a decision guide to support the elderly in decision making about location of care: an iterative, user-centered design. Res Involv Engagem. 2016 Jul 19;2:26. doi: 10.1186/s40900-016-0040-0. eCollection 2016.
PubMed 29062524Pot AM, Willemse BM, Horjus S. A pilot study on the use of tracking technology: feasibility, acceptability, and benefits for people in early stages of dementia and their informal caregivers. Aging Ment Health. 2012;16(1):127-34. doi: 10.1080/13607863.2011.596810. Epub 2011 Jul 25.
PubMed 21780960Greenhalgh T, Jackson C, Shaw S, Janamian T. Achieving Research Impact Through Co-creation in Community-Based Health Services: Literature Review and Case Study. Milbank Q. 2016 Jun;94(2):392-429. doi: 10.1111/1468-0009.12197.
PubMed 27265562Meijering L, Weitkamp G. Numbers and narratives: Developing a mixed-methods approach to understand mobility in later life. Soc Sci Med. 2016 Nov;168:200-206. doi: 10.1016/j.socscimed.2016.06.007. Epub 2016 Jun 8.
PubMed 27316320Sturge J, Meijering L, Jones CA, Garvelink M, Caron D, Nordin S, Elf M, Legare F. Technology to Improve Autonomy and Inform Housing Decisions for Older Adults With Memory Problems Who Live at Home in Canada, Sweden, and the Netherlands: Protocol for a Multipronged Mixed Methods Study. JMIR Res Protoc. 2021 Jan 21;10(1):e19244. doi: 10.2196/19244.
PubMed 33475512
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology to Support Decision Making About Aging at Home (COORDINATEs)
- ClinicalTrials.gov ID
- NCT04267484
- Acronym / sponsor ID
- COORDINATEs / 118792
- Keywords
- Shared decision making, Mild Cognitive Impairment, Technology, aging in place, memory problem
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Laval University, Dalarna University, University of Groningen, University of Alberta
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 13 Feb 2020 (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.
Most older people want to stay at home as long as possible. Effective self-management for people losing autonomy depends on reliable monitoring of their mobility, health and safety and active implication in decision-making. New technologies have the potential to provide information about changing patterns that reflect changing care needs. This information could help older adults, caregivers and health professionals to participate in decision-making about housing options when a change in living environment needs to be considered.
Detailed description
This is a multi-phase study to be conducted in 3 countries: Canada (Quebec and Alberta), Sweden and Netherlands. The primary objective is to provide e-decision support technology that will facilitate self-management in the context of aging in place and foster informed value congruent decisions about options to age safely at home.
The aim of the project is to develop and validate a e-technology based on already existing components (e.g. GPS devices, diverse e-platforms and decision support interventions) to 1) help older adults with mild cognitive impairment/memory problems to stay safely at home as long as possible and 2) to provide older adults with decision support tools to help them make informed value congruent decisions (e.g. foster a shared decision-making process) regarding aging at home in a safe manner.
The secondary objectives are:
- Assess autonomy and mobility of older adults with mild cognitive impairment/memory problems living at home.
- Inform shared decision-making processes about options to safely age in place for all those involved.
The investigators will apply an integrated Knowledge Translation (iKT), comparative, mixed-methods approach to explore, older adults living at home with mild cognitive impairment/memory problems, their use of space in their homes and neighbourhoods.
The project is divide into 4 work package (WP). In more details, during WP1, the investigators will collect spatial data (e.g. using GPS) and self-reported data (e.g. travel diaries, walking interviews, in-depth interviews, surveys). At WP2, the investigators will use iterative end-user feedback and end-user consultation discussion group to tailor a decision support technology to knowledge-users. At WP3, investigators will assess user opinion regarding factors that could influence their use of the newly adapted e-decision support technology. Finally, at WP4 the investigators will triangulate data and take into account differences between jurisdictions.
This collaboration and our cross-country comparisons will contribute to scaling up e-decision support solutions in the future for the older adults with mild cognitive impairment/memory problems who want to age safely at home.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older adults with mild cognitive impairment | – | Device: GPS and travel diary, Other: e-decision support platformWP1, older adults with cognitive impairment will use a GPS tracker for 2 weeks, during which they are asked 1) to keep a daily diary about their activity (travel diary), 2) take the researcher on a walk that they often do (walking interview), and 3) participate in an in-depth interview after 2 weeks, in which their experience with the GPS ans the travel diary data are discussed. WP2, older adults with mild cognitive impairment, caregivers, health professionals and technology developers will collaborate during group discussion meeting to co-design the e-decision support platform to be adapted. WP3, older adults with mild cognitive impairment, caregivers and health professionals will then be asked to use the adapted e-decision support platform and fill a survey. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly (>65 years) with mild cognitive impairment or self reported memory problems.
Key inclusion criteria (5 listed)
- Aged ≥ 65 years
- Living at home
- Diagnosed with mild cognitive impairment or experiencing memory issues
- Able to read, understand and write
- Can provide informed consent
Key exclusion criteria (2 listed)
- Older adults who are not able to provide informed consent
- Living in nursing home or hospital
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 |
|---|---|---|
| GPS and travel diaryWP1: GPS tracker for 2 weeks and a daily diary about activity (travel diary). | Device | Older adults with mild cognitive impairment |
| e-decision support platformWP2 and WP3: An e-decision support platform that will foster shared decision making about options to stay safe at home for the older adult. | Other | Older adults with mild cognitive impairment |
Primary outcome
Autonomy and mobility assessment using GPS
Time frame: Participant will wear a GPS for a total of two weeks. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
WP1: 1) Asses autonomy and mobility of older adults with mild cognitive impairment and memory problems living at home (including caregivers), their movement through their homes and neighborhoods (using GPS and walking interview); 2) how GPS data can support ongoing SDM about housing options for older adults.
Iterative assessment to tailor the e-decision support technology
Time frame: Immediately after group discussion. 3 sequential group discussion are plan to occur, one in each country (Canada, Sweden, Netherlands) data collection will happen over a period of 1 year.
WP2: 1) Group discussion on if and how to incorporate GPS and adaptation of an existing e-platforms to create an adapted e-decision support technology (noted that the discussion focus will depend on result from WP1).
User experience assessment of the newly adapted technology
Time frame: Immediately after testing the new platform. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands), it will happen over a period of 6 months
WP3: 1) Opinion of older adults with mild cognitive impairment, caregivers and health professionals about the adapted technology (noted that the final survey will depend on result from WP1 and WP2).
2 secondary outcomes
Inform SDM processes about housing option
Time frame: 9 months
Open-ended questionnaire of participant global health status and their experience of using the GPS and filling the travel diary
Time frame: Immediately before and after carrying the GPS at WP1. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Results publication: PubMed 16821201Caron CD, Ducharme F, Griffith J. Deciding on institutionalization for a relative with dementia: the most difficult decision for caregivers. Can J Aging. 2006 Summer;25(2):193-205. doi: 10.1353/cja.2006.0033.
- Results publication: PubMed 29062524Garvelink MM, Emond J, Menear M, Briere N, Freitas A, Boland L, Perez MMB, Blair L, Stacey D, Legare F. Development of a decision guide to support the elderly in decision making about location of care: an iterative, user-centered design. Res Involv Engagem. 2016 Jul 19;2:26. doi: 10.1186/s40900-016-0040-0. eCollection 2016.
- Results publication: PubMed 21780960Pot AM, Willemse BM, Horjus S. A pilot study on the use of tracking technology: feasibility, acceptability, and benefits for people in early stages of dementia and their informal caregivers. Aging Ment Health. 2012;16(1):127-34. doi: 10.1080/13607863.2011.596810. Epub 2011 Jul 25.
- Results publication: PubMed 27265562Greenhalgh T, Jackson C, Shaw S, Janamian T. Achieving Research Impact Through Co-creation in Community-Based Health Services: Literature Review and Case Study. Milbank Q. 2016 Jun;94(2):392-429. doi: 10.1111/1468-0009.12197.
- Results publication: PubMed 27316320Meijering L, Weitkamp G. Numbers and narratives: Developing a mixed-methods approach to understand mobility in later life. Soc Sci Med. 2016 Nov;168:200-206. doi: 10.1016/j.socscimed.2016.06.007. Epub 2016 Jun 8.
- Derived from this study: PubMed 33475512Sturge J, Meijering L, Jones CA, Garvelink M, Caron D, Nordin S, Elf M, Legare F. Technology to Improve Autonomy and Inform Housing Decisions for Older Adults With Memory Problems Who Live at Home in Canada, Sweden, and the Netherlands: Protocol for a Multipronged Mixed Methods Study. JMIR Res Protoc. 2021 Jan 21;10(1):e19244. doi: 10.2196/19244.
- Chaire de recherche du Canada sur la décision partagée et l'application des connaissancesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
France Légaré, PhD principal investigator
Laval University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Memory Problems and Aging, run by CHU de Quebec-Universite Laval at 4 sites in 3 countries.
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 5 inclusion and 2 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, Netherlands, Sweden. 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 France Légaré, PhD (418-663-5919 ext. 8100, francelegare@mfa.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomy and mobility assessment using GPS (time frame: Participant will wear a GPS for a total of two weeks. As data collection will occur in parallel at all four sites (Quebec, Alberta, Sweden, Netherlands) data collection will happen over a period of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267484, which also lists 6 linked publications.
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 17 Feb 2020.