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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03263169
Other study ID # HealthTap-WEPilot
Secondary ID
Status Recruiting
Phase N/A
First received August 21, 2017
Last updated August 23, 2017
Start date July 1, 2017
Est. completion date September 30, 2018

Study information

Verified date August 2017
Source Windsor-Essex Compassionate Care Community
Contact Deborah Sattler
Phone 974-2581
Email deborah@deborahsattler.ca
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.

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?


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1100
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Community-based personalized care
volunteer support, health technology, interprofessional care, social network linkage

Locations

Country Name City State
Canada Windsor-Essex Compassionate Care Community Program Management Office Windsor Ontario

Sponsors (6)

Lead Sponsor Collaborator
Windsor-Essex Compassionate Care Community Erie-St. Clair Local Health Integration Network, Green Shield Canada Inc., McMaster University, University of Western Ontario, Canada, University of Windsor

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life McGill QoL - patient and family Baseline and then monthly for 24 months
Primary Perceived health EQ-5D-5L - patient Baseline and then monthly for 24 months
Secondary Caregiver Burden 1 InterRAI-home care Baseline and then monthly for 24 months
Secondary Caregiver Burden 2 Zarit burden interview Baseline and then monthly for 24 months
Secondary Patient experience CANHelp Patient Baseline and then monthly for 24 months
Secondary Family experience CANHelp Family Baseline and then monthly for 24 months
Secondary Symptom management 1 Edmonton Symptom Assessment Scale Baseline and then monthly for 24 months
Secondary Symptom management 2 Palliative Performance Scale Baseline and then monthly for 24 months
Secondary Symptom management 3 InterRAI-home care Baseline and then monthly for 24 months
Secondary Health services utilization 1 hospitalization Baseline and then monthly for 24 months
Secondary Health services utilization 2 Emergency care Baseline and then monthly for 24 months
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