Community-based Personalized Care and QOL

Aging Clinical Trial

Official title:

A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03263169
• Other study ID #: HealthTap-WEPilot
• 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
• 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

Related Conditions & MeSH terms

• Aging
• Chronic Disease
• Disability or Chronic Disease Leading to Disablement

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