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What Are my Options to Stay Safe at Home: Technology For Aging at Home (COORDINATEs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04267484
Recruitment Status : Recruiting
First Posted : February 13, 2020
Last Update Posted : February 17, 2020
Sponsor:
Collaborators:
Laval University
Dalarna University
University of Groningen
University of Alberta
Information provided by (Responsible Party):
France Legare, CHU de Quebec-Universite Laval

Brief 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. 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.

Condition or disease Intervention/treatment
Memory Problems Aging Mild Cognitive Impairment Shared Decision Making Device: GPS and travel diary Other: e-decision support platform

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:

  1. Assess autonomy and mobility of older adults with mild cognitive impairment/memory problems living at home.
  2. 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.

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Study Type : Observational
Estimated Enrollment : 294 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Technology to Support Decision Making About Aging at Home (COORDINATEs)
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.

Device: GPS and travel diary
WP1: GPS tracker for 2 weeks and a daily diary about activity (travel diary).

Other: e-decision support platform
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).


Secondary Outcome Measures :
  1. Inform SDM processes about housing option [ Time Frame: 9 months ]
    WP4: 1) Knowledge about differences and similarities between three countries

  2. 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 ]
    WP1: Participant will be ask to share their experience with the GPS and the travel diary



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly (>65 years) with mild cognitive impairment or self reported memory problems.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Older adults who are not able to provide informed consent
  • Living in nursing home or hospital

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267484


Contacts
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Contact: France Légaré, PhD 418-663-5919 ext 8100 francelegare@mfa.ulaval.ca
Contact: Danielle Caron, PhD 418-663-5689 danielle.caro3.ciussscn@ssss.gouv.qc.ca

Locations
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Canada, Quebec
CERSSPL Recruiting
Québec, Quebec, Canada
Contact: France Légaré, MD, PhD         
Canada
University of Alberta Recruiting
Edmonton, Canada
Contact: Allyson Jones         
Netherlands
University of Groningen Recruiting
Groningen, Netherlands
Contact: Louise Meijering         
Sweden
Dalarna University Recruiting
Falun, Sweden
Contact: Marie Elf         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Laval University
Dalarna University
University of Groningen
University of Alberta
Investigators
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Principal Investigator: France Légaré, PhD Laval University

Additional Information:
Publications of Results:
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Responsible Party: France Legare, Principal investigator, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT04267484    
Other Study ID Numbers: 118792
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by France Legare, CHU de Quebec-Universite Laval:
Shared decision making
Mild Cognitive Impairment
Technology
aging in place
memory problem
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders