Condition category
Not Applicable
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
16/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jane Elizabeth Drummond

ORCID ID

Contact details

Health Sciences Council
300 Campus Tower
8625
112 Street
Edmonton
Alberta
T6G 1K8
Canada
+1 780 492 2861
jane.drummond@ualberta.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-75478

Study information

Scientific title

Families first Edmonton: The comparative effects and expense of four models of augmenting services for low-income families

Acronym

FFE

Study hypothesis

Low-income families who receive primary health care (PRMHLTH) and/or Recreation Coordination (REC) will initially increase uptake of linkages to services, costs to service systems will decrease over time, and the physical and psychosocial health of family members will increase over time.

Ethics approval

Health Research Ethics Board of University of Alberta, Edmonton, Alberta, Canada, approved on the 5th September 2006 (ref: B-030704)

Study design

Single centre prevention, behavioural, and educational intervention type, four-armed randomised factorial trial with outcome assessor blinding

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Physical and psychosocial health

Intervention

This trial will test four service delivery models:
1. The Control Model (EXIST)
2. The Primary Health Care Model (PRMHLTH)
3. The Recreation Coordination Model (REC)
4. The Comprehensive Model (COMP)

These service delivery models and the practices associated with them are designed primarily to:
1. Build and sustain low-income family-initiated linkages to established government and community services, and
2. Reduce overall costs to health and social service sectors by increasing cost-effective use of preventive and health promotional services

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

1. Characteristics of linkages between families and services
2. Costs to service systems
3. Adult physical health
4. Adult psychosocial health
5. Child physical health
6. Child psychosocial health

Overall trial start date

01/11/2005

Overall trial end date

01/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Participant families will:
1. Have received low-income assistance (Income Support [IS] or Alberta Child Health Benefit [ACHB]) continuously for over 12 months
2. Have a child or children between zero and 18 years of age, either sex
3. Reside in designated geographic areas that serves many low-income families, and
4. Be able to provide signed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

Potential study participants will be excluded:
1. If they refuse to give informed consent to be interviewed
2. If they are unable to read and write English and an appropriate translator is not available
3. If they have plans to move outside the regions, or
4. If they are unwilling to participate for the entire follow-up period

Recruitment start date

01/11/2005

Recruitment end date

01/02/2007

Locations

Countries of recruitment

Canada

Trial participating centre

Health Sciences Council
Alberta
T6G 1K8
Canada

Sponsor information

Organisation

University of Alberta (Canada)

Sponsor details

c/o Bonnie Albrecht
Agreements Manager
222 Campus Towers
Edmonton
Alberta
T6G 0Y1
Canada
+1 780 492 9705
bonnie.albrecht@ualberta.ca

Sponsor type

University/education

Website

http://www.ualberta.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75478)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Alberta Heritage Foundation for Medical Research (AHFMR) (Canada)

Alternative name(s)

AHFMR

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes