ISRCTN ISRCTN65556220
DOI https://doi.org/10.1186/ISRCTN65556220
Secondary identifying numbers MCT-75478
Submission date
26/02/2007
Registration date
26/02/2007
Last edited
16/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jane Elizabeth Drummond
Scientific

Health Sciences Council
300 Campus Tower
8625, 112 Street
Edmonton
Alberta
T6G 1K8
Canada

Phone +1 780 492 2861
Email jane.drummond@ualberta.ca

Study information

Study designSingle centre prevention, behavioural, and educational intervention type, four-armed randomised factorial trial with outcome assessor blinding
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Scientific titleFamilies first Edmonton: The comparative effects and expense of four models of augmenting services for low-income families
Study acronymFFE
Study objectivesLow-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(s)Health Research Ethics Board of University of Alberta, Edmonton, Alberta, Canada, approved on the 5th September 2006 (ref: B-030704)
Health condition(s) or problem(s) studiedPhysical and psychosocial health
InterventionThis 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 typeOther
Primary outcome measureIncreased linkages between low-income families and established services in their communities.
Secondary outcome measures1. 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 study start date01/11/2005
Completion date01/02/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1200
Key inclusion criteriaParticipant 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
Key exclusion criteriaPotential 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
Date of first enrolment01/11/2005
Date of final enrolment01/02/2007

Locations

Countries of recruitment

  • Canada

Study participating centre

Health Sciences Council
Alberta
T6G 1K8
Canada

Sponsor information

University of Alberta (Canada)
University/education

c/o Bonnie Albrecht, Agreements Manager
222 Campus Towers
Edmonton
Alberta
T6G 0Y1
Canada

Phone +1 780 492 9705
Email bonnie.albrecht@ualberta.ca
Website http://www.ualberta.ca/
ROR logo "ROR" https://ror.org/0160cpw27

Funders

Funder type

Research organisation

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

No information available

Alberta Heritage Foundation for Medical Research (AHFMR) (Canada)
Government organisation / Local government
Alternative name(s)
AHFMR
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan