NCT00705328

Brief Summary

This study is designed to provide clear evidence for health and social policymakers about the influence of alternate service-delivery models and practices on enhancing and sustaining low-income family linkages to available services. A challenge faced by Canadian health and social service providers is to promote health for low-income families in a proactive and cost-effective manner. Families with low incomes experience an array of health and social barriers that compromise their resilience, lead to negative family outcomes, and act as barriers to available services. Family barriers are compounded by service delivery barriers and result in reduced opportunities for effective, primary-level services and in increased use of secondary-level services (e.g., emergency room visits, emergency intervention, police involvement), with the obvious increase in costs. Randomized-controlled trials are rare in community-based intervention research. This Families First Edmonton randomized-controlled trial (RCT) will enable testing of innovative service-delivery models and provide an opportunity for evidence-based decision making for Canadian policy makers. Critical information will be provided about

  1. 1.optimizing cost effectiveness for public systems
  2. 2.the long-term effects on the health of low-income family members
  3. 3.mechanisms that intervene between the interventions and their effect on the health of low-income family members
  4. 4.building on previous research and on community-based initiatives
  5. 5.promoting knowledge transfer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

5.5 years

First QC Date

June 24, 2008

Last Update Submit

April 20, 2016

Conditions

Keywords

low-income familieschildrenrecreationfamily healthy lifestylelinkages to community resourcesFamilies with low incomesworking poorwelfare recipients

Outcome Measures

Primary Outcomes (1)

  • Increased linkages between low income families and established services in their communities

    Baseline, 12-month, 24-month, 36-month follow-up

Study Arms (3)

1

EXPERIMENTAL
Behavioral: Primary Health Care Model (PRMHLTH)

2

EXPERIMENTAL
Behavioral: Recreation Coordination Model (REC)

3

EXPERIMENTAL
Behavioral: Comprehensive Model (COMP)

Interventions

Primary health care service delivery

1

Recreation coordination service delivery

2

a comprehensive service delivery model consisting of PRMHLTH plus REC.

3

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participant families will
  • have received low-income assistance either in the form of
  • Alberta Works Income Support
  • Alberta Child Health Benefits,
  • Alberta Works Adult Health Benefits
  • participating in City of Edmonton Leisure Access Program
  • living in Capital Region Housing
  • have a child or children between 0 and 12 years of age
  • reside in city of Edmonton
  • be able to provide signed consent

You may not qualify if:

  • Potential study participants will be excluded if they refuse to give informed consent to be interviewed
  • are unable to read and write English and an appropriate translator is not available
  • have plans to move outside the region
  • are unwilling to participate for the entire follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Human Resources and Employment

Edmonton, Alberta, T5A 1C6, Canada

Location

Related Publications (3)

  • Browne G, Byrne C, Roberts J, Gafni A, Whittaker S. When the bough breaks: provider-initiated comprehensive care is more effective and less expensive for sole-support parents on social assistance. Soc Sci Med. 2001 Dec;53(12):1697-710. doi: 10.1016/s0277-9536(00)00455-x.

    PMID: 11762894BACKGROUND
  • Drummond J, Wiebe N, So S, Schnirner L, Bisanz J, Williamson DL, Mayan M, Templeton L, Fassbender K; Community-University Partnership for the Study of Children, Youth, and Families. Service-integration approaches for families with low income: a Families First Edmonton, community-based, randomized, controlled trial. Trials. 2016 Jul 22;17:343. doi: 10.1186/s13063-016-1444-8.

  • Drummond J, Schnirer L, So S, Mayan M, Williamson DL, Bisanz J, Fassbender K, Wiebe N. The protocol for the Families First Edmonton trial (FFE): a randomized community-based trial to compare four service integration approaches for families with low-income. BMC Health Serv Res. 2014 May 19;14:223. doi: 10.1186/1472-6963-14-223.

Study Officials

  • Jane Drummond, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Provost - Health Sciences Council; Professor - Nursing

Study Record Dates

First Submitted

June 24, 2008

First Posted

June 26, 2008

Study Start

December 1, 2005

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations