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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00705328
Other study ID # 137444
Secondary ID
Status Completed
Phase Phase 2
First received June 24, 2008
Last updated April 20, 2016
Start date December 2005
Est. completion date June 2011

Study information

Verified date April 2016
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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. optimizing cost effectiveness for public systems

2. the long-term effects on the health of low-income family members

3. mechanisms that intervene between the interventions and their effect on the health of low-income family members

4. building on previous research and on community-based initiatives

5. promoting knowledge transfer


Recruitment information / eligibility

Status Completed
Enrollment 2400
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Participant families will

1. have received low-income assistance either in the form of

1. Alberta Works Income Support

2. Alberta Child Health Benefits,

3. Alberta Works Adult Health Benefits

4. participating in City of Edmonton Leisure Access Program

5. living in Capital Region Housing

2. have a child or children between 0 and 12 years of age

3. reside in city of Edmonton

4. be able to provide signed consent

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Primary Health Care Model (PRMHLTH)
Primary health care service delivery
Recreation Coordination Model (REC)
Recreation coordination service delivery
Comprehensive Model (COMP)
a comprehensive service delivery model consisting of PRMHLTH plus REC.

Locations

Country Name City State
Canada Alberta Human Resources and Employment Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increased linkages between low income families and established services in their communities Baseline, 12-month, 24-month, 36-month follow-up No
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