NCT03263169

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 28, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 21, 2017

Last Update Submit

August 23, 2017

Conditions

AgingDisability or Chronic Disease Leading to Disablement

Keywords

e-health, community networks, pragmatic RCT

Outcome Measures

Primary Outcomes (2)

  • Quality of Life

    McGill QoL - patient and family

    Baseline and then monthly for 24 months

  • Perceived health

    EQ-5D-5L - patient

    Baseline and then monthly for 24 months

Secondary Outcomes (9)

  • Caregiver Burden 1

    Baseline and then monthly for 24 months

  • Caregiver Burden 2

    Baseline and then monthly for 24 months

  • Patient experience

    Baseline and then monthly for 24 months

  • Family experience

    Baseline and then monthly for 24 months

  • Symptom management 1

    Baseline and then monthly for 24 months

  • +4 more secondary outcomes

Study Arms (2)

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

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

Interventions

Community-based personalized careBEHAVIORAL

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

Usual CareWE Health Tapestry

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Individuals not meeting above criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Windsor-Essex Compassionate Care Community Program Management Office

Windsor, Ontario, N8T 1B5, Canada

RECRUITING

Study Officials

  • Michelle Howard, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Lisa Dolovich, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Kathryn Pfaff, PhD

    University of Windsor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deborah Sattler

CONTACT

974-2581deborah@deborahsattler.ca

Kathryn A Pfaff, PhD

CONTACT

253-3000kpfaff@uwindsor.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 28, 2017

Study Start

July 1, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations

CA(1)