Community-based Personalized Care and QOL

NCT ID: NCT03263169

Last Updated: 2017-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-09-30

Brief Summary

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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

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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.

Conditions

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Aging Disability or Chronic Disease Leading to Disablement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Community-based personalized care

Intervention Type BEHAVIORAL

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

Community-based personalized care

Intervention Type BEHAVIORAL

volunteer support, health technology, interprofessional care, social network linkage

Interventions

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Community-based personalized care

volunteer support, health technology, interprofessional care, social network linkage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Windsor

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

University of Western Ontario, Canada

OTHER

Sponsor Role collaborator

Green Shield Canada Inc.

INDUSTRY

Sponsor Role collaborator

Erie St. Clair Local Health Integration Network (LHIN)

OTHER

Sponsor Role collaborator

Windsor-Essex Compassionate Care Community

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Howard, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Lisa Dolovich, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Kathryn Pfaff, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Windsor

Locations

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Windsor-Essex Compassionate Care Community Program Management Office

Windsor, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Deborah Sattler

Role: CONTACT

974-2581 ext. 2420

Kathryn A Pfaff, PhD

Role: CONTACT

253-3000 ext. 4977

Facility Contacts

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Deborah Sattler

Role: primary

519-974-2581 ext. 2420

Diane Halbgewachs

Role: backup

519-974-2581 ext. 2420

Other Identifiers

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HealthTap-WEPilot

Identifier Type: -

Identifier Source: org_study_id

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