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Community-based Personalized Care and QOL

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ClinicalTrials.gov Identifier: NCT03263169
Recruitment Status : Recruiting
First Posted : August 28, 2017
Last Update Posted : August 28, 2017
Sponsor:
Collaborators:
University of Windsor
McMaster University
University of Western Ontario, Canada
Green Shield Canada Inc.
Erie St. Clair Local Health Integration Network (LHIN)
Information provided by (Responsible Party):
Windsor-Essex Compassionate Care Community

Brief 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.

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?


Condition or disease Intervention/treatment
Aging Disability or Chronic Disease Leading to Disablement Behavioral: Community-based personalized care

Detailed Description:

Secondary research questions include:

  1. 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?
  2. 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?
  3. 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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Group/Cohort Intervention/treatment
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
Behavioral: Community-based personalized care
volunteer support, health technology, interprofessional care, social network linkage

Usual Care
Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage
Behavioral: Community-based personalized care
volunteer support, health technology, interprofessional care, social network linkage




Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Baseline and then monthly for 24 months ]
    McGill QoL - patient and family

  2. Perceived health [ Time Frame: Baseline and then monthly for 24 months ]
    EQ-5D-5L - patient


Secondary Outcome Measures :
  1. Caregiver Burden 1 [ Time Frame: Baseline and then monthly for 24 months ]
    InterRAI-home care

  2. Caregiver Burden 2 [ Time Frame: Baseline and then monthly for 24 months ]
    Zarit burden interview

  3. Patient experience [ Time Frame: Baseline and then monthly for 24 months ]
    CANHelp Patient

  4. Family experience [ Time Frame: Baseline and then monthly for 24 months ]
    CANHelp Family

  5. Symptom management 1 [ Time Frame: Baseline and then monthly for 24 months ]
    Edmonton Symptom Assessment Scale

  6. Symptom management 2 [ Time Frame: Baseline and then monthly for 24 months ]
    Palliative Performance Scale

  7. Symptom management 3 [ Time Frame: Baseline and then monthly for 24 months ]
    InterRAI-home care

  8. Health services utilization 1 [ Time Frame: Baseline and then monthly for 24 months ]
    hospitalization

  9. Health services utilization 2 [ Time Frame: Baseline and then monthly for 24 months ]
    Emergency care



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

Individuals who:

  1. are 65 years of age and over
  2. have a long-term disability or one or more chronic diseases
  3. able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement

Exclusion Criteria:

Individuals not meeting above criteria


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): NCT03263169


Contacts
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Contact: Deborah Sattler 974-2581 ext 2420 deborah@deborahsattler.ca
Contact: Kathryn A Pfaff, PhD 253-3000 ext 4977 kpfaff@uwindsor.ca

Locations
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Canada, Ontario
Windsor-Essex Compassionate Care Community Program Management Office Recruiting
Windsor, Ontario, Canada, N8T 1B5
Contact: Deborah Sattler    519-974-2581 ext 2420    deborah@deborahsattler.ca   
Contact: Diane Halbgewachs    519-974-2581 ext 2420    DHalbgewachs2@thehospice.ca   
Principal Investigator: Michelle Howard, PhD         
Sub-Investigator: Lisa Dolovich, PhD         
Sub-Investigator: Kathryn Pfaff, PhD         
Sub-Investigator: Merrick Zwarenstein, PhD         
Sponsors and Collaborators
Windsor-Essex Compassionate Care Community
University of Windsor
McMaster University
University of Western Ontario, Canada
Green Shield Canada Inc.
Erie St. Clair Local Health Integration Network (LHIN)
Investigators
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Principal Investigator: Michelle Howard, PhD McMaster University
Principal Investigator: Lisa Dolovich, PhD McMaster University
Principal Investigator: Kathryn Pfaff, PhD University of Windsor

Additional Information:

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Responsible Party: Windsor-Essex Compassionate Care Community
ClinicalTrials.gov Identifier: NCT03263169     History of Changes
Other Study ID Numbers: HealthTap-WEPilot
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Windsor-Essex Compassionate Care Community:
e-health, community networks, pragmatic RCT

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes