AgingNCT03263169
Community-based Personalized Care and QOL
An observational study of Aging and Disability or Chronic Disease Leading to Disablement, run by Windsor-Essex Compassionate Care Community at 1 site in Canada.
Trial summary
A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Disability or Chronic Disease Leading to Disablement
- What is being tested?
- Community-based personalized care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2017to 30 Sep 2018
- How long will I take part?
- 2 Years
- 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
- Healthy volunteers accepted
- Older adult
Study population: Seniors who identify with having a functional disability or serious chronic disease; and informal caregivers. Many patients within this broad target population will be at risk of worsening quality of life or escalating health care utilization now or in the future due to aging, disease progression, or unmet health, social or economic needs.
Who may be able to join
- Individuals who:
- are 65 years of age and over
- have a long-term disability or one or more chronic diseases
- able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement
Who cannot join
- Individuals not meeting above criteria
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Windsor-Essex Compassionate Care Community Program Management Office
Windsor, Ontario, N8T 1B5
Deborah Sattler, 519-974-2581 ext. 2420, deborah@deborahsattler.ca
Diane Halbgewachs, 519-974-2581 ext. 2420, DHalbgewachs2@thehospice.ca
About this study
Official title: A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults
A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology.
The primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?
Read the detailed description
Secondary research questions include:
- what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection?
- What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention?
- what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence?
The project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation.
Inclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn
In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients.
The primary outcomes are quality of life (QOL); perceived health; experience of care, and perceived social connection.
The primary outcomes for caregivers will be quality of life; perceived burden; caregiver perceptions of care; and perceived social connection.
Secondary outcomes for both will include goal attainment, distress management, symptom management, places of care, and health care utilization and costs. In terms of health equity, the investigators will measure the difference between the average/median population quality of life and cost outcomes compared to patients at the bottom income quartiles stratified by risk level. At a systems level, algorithms will be developed and applied to the data collected from participants to provide aggregate organization and system-level reports, co-designed with end users to support them as learning organizations.
- Being tested
- Community-based personalized care
- Keywords
- e-health, community networks, pragmatic RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based personalized careBehavioural
volunteer support, health technology, interprofessional care, social network linkage
| Study group | Role | What they receive |
|---|---|---|
| WE Health Tapestry | Completion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage Receives: Behavioral: Community-based personalized care | |
| Usual Care | Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage Receives: Behavioral: Community-based personalized care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life
McGill QoL - patient and family
Measured: Baseline and then monthly for 24 months
Perceived health
EQ-5D-5L - patient
Measured: Baseline and then monthly for 24 months
Secondary outcomes (9)
Caregiver Burden 1
InterRAI-home care
Measured: Baseline and then monthly for 24 months
Caregiver Burden 2
Zarit burden interview
Measured: Baseline and then monthly for 24 months
Patient experience
CANHelp Patient
Measured: Baseline and then monthly for 24 months
Family experience
CANHelp Family
Measured: Baseline and then monthly for 24 months
Symptom management 1
Edmonton Symptom Assessment Scale
Measured: Baseline and then monthly for 24 months
Symptom management 2
Palliative Performance Scale
Measured: Baseline and then monthly for 24 months
Symptom management 3
InterRAI-home care
Measured: Baseline and then monthly for 24 months
Health services utilization 1
hospitalization
Measured: Baseline and then monthly for 24 months
Health services utilization 2
Emergency care
Measured: Baseline and then monthly for 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Jul 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Prospective
- Enrolment
- 1,100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Windsor-Essex Compassionate Care Community
- Sponsor type
- University, hospital or other
- Collaborators
- University of Windsor, McMaster University, University of Western Ontario, Canada, Green Shield Canada Inc., Erie St. Clair Local Health Integration Network (LHIN)
- Responsible party
- Sponsor
- Investigators
- Michelle Howard, PhD, Principal investigator, McMaster UniversityLisa Dolovich, PhD, Principal investigator, McMaster UniversityKathryn Pfaff, PhD, Principal investigator, University of Windsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263169
- Sponsor's protocol ID
- HealthTap-WEPilot
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults
- ClinicalTrials.gov ID
- NCT03263169
- Acronym / sponsor ID
- HealthTap-WEPilot
- Keywords
- e-health, community networks, pragmatic RCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Windsor-Essex Compassionate Care CommunityUniversity, hospital or other
- Collaborators
- University of Windsor, McMaster University, University of Western Ontario, Canada, Green Shield Canada Inc., Erie St. Clair Local Health Integration Network (LHIN)
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 28 Aug 2017 (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.
A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology.
The primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?
Detailed description
Secondary research questions include:
- what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection?
- What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention?
- what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence?
The project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation.
Inclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn
In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients.
The primary outcomes are quality of life (QOL); perceived health; experience of care, and perceived social connection.
The primary outcomes for caregivers will be quality of life; perceived burden; caregiver perceptions of care; and perceived social connection.
Secondary outcomes for both will include goal attainment, distress management, symptom management, places of care, and health care utilization and costs. In terms of health equity, the investigators will measure the difference between the average/median population quality of life and cost outcomes compared to patients at the bottom income quartiles stratified by risk level. At a systems level, algorithms will be developed and applied to the data collected from participants to provide aggregate organization and system-level reports, co-designed with end users to support them as learning organizations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WE Health Tapestry | – | Behavioral: Community-based personalized careCompletion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage |
| Usual Care | – | Behavioral: Community-based personalized careCompletion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Seniors who identify with having a functional disability or serious chronic disease; and informal caregivers. Many patients within this broad target population will be at risk of worsening quality of life or escalating health care utilization now or in the future due to aging, disease progression, or unmet health, social or economic needs.
Key inclusion criteria (4 listed)
- are 65 years of age and over
- have a long-term disability or one or more chronic diseases
- able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement
Key exclusion criteria (1 listed)
- Individuals not meeting above criteria
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 |
|---|---|---|
| Community-based personalized carevolunteer support, health technology, interprofessional care, social network linkage | Behavioural | Usual Care, WE Health Tapestry |
Primary outcome
Quality of Life
Time frame: Baseline and then monthly for 24 months
McGill QoL - patient and family
Perceived health
Time frame: Baseline and then monthly for 24 months
EQ-5D-5L - patient
9 secondary outcomes
Caregiver Burden 1
Time frame: Baseline and then monthly for 24 months
Caregiver Burden 2
Time frame: Baseline and then monthly for 24 months
Patient experience
Time frame: Baseline and then monthly for 24 months
Family experience
Time frame: Baseline and then monthly for 24 months
Symptom management 1
Time frame: Baseline and then monthly for 24 months
Symptom management 2
Time frame: Baseline and then monthly for 24 months
Symptom management 3
Time frame: Baseline and then monthly for 24 months
Health services utilization 1
Time frame: Baseline and then monthly for 24 months
Health services utilization 2
Time frame: Baseline and then monthly for 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Michelle Howard, PhD principal investigator
McMaster University
Lisa Dolovich, PhD principal investigator
McMaster University
Kathryn Pfaff, PhD principal investigator
University of Windsor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Disability or Chronic Disease Leading to Disablement, run by Windsor-Essex Compassionate Care Community at 1 site in Canada.
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 4 inclusion and 1 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 28 Aug 2017. 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 Canada. 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 Deborah Sattler (974-2581 ext. 2420, deborah@deborahsattler.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life (time frame: Baseline and then monthly for 24 months). The study lists 2 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 28 Aug 2017.