Low-Income PopulationPhase 2FFENCT00705328
Families First Edmonton (FFE)
A Phase 2 study testing Primary Health Care Model (PRMHLTH), Recreation Coordination Model (REC) and Comprehensive Model (COMP) in people with Low-Income Population, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Low-Income Population
- What is being tested?
- Primary Health Care Model (PRMHLTH), Recreation Coordination Model (REC) and Comprehensive Model (COMP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2005to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Families First Edmonton: The Comparative Effects and Expense of Four Models of Augmenting Services for Low-income Families
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
- optimizing cost effectiveness for public systems
- the long-term effects on the health of low-income family members
- mechanisms that intervene between the interventions and their effect on the health of low-income family members
- building on previous research and on community-based initiatives
- promoting knowledge transfer
- Conditions
- Low-Income Population
- Being tested
- Primary Health Care Model (PRMHLTH), Recreation Coordination Model (REC), Comprehensive Model (COMP)
- Keywords
- low-income families, children, recreation, family healthy lifestyle, linkages to community resources, Families with low incomes, working poor, welfare recipients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Health Care Model (PRMHLTH)Behavioural
Primary health care service delivery
Recreation Coordination Model (REC)Behavioural
Recreation coordination service delivery
Comprehensive Model (COMP)Behavioural
a comprehensive service delivery model consisting of PRMHLTH plus REC.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Primary Health Care Model (PRMHLTH) |
| 2 | Experimental | Not described Receives: Behavioral: Recreation Coordination Model (REC) |
| 3 | Experimental | Not described Receives: Behavioral: Comprehensive Model (COMP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased linkages between low income families and established services in their communities
Measured: Baseline, 12-month, 24-month, 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startDec 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low-Income PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Mayan, University of Alberta
- Investigators
- Jane Drummond, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705328
- Sponsor's protocol ID
- 137444
- Acronym
- FFE
- Status last verified
- Apr 2016
- First submitted
- 24 Jun 2008
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11762894Drummond 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.
PubMed 27449358Drummond 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.
PubMed 24885729
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Families First Edmonton: The Comparative Effects and Expense of Four Models of Augmenting Services for Low-income Families
- ClinicalTrials.gov ID
- NCT00705328
- Acronym / sponsor ID
- FFE / 137444
- Conditions
- Low-Income Population
- Keywords
- low-income families, children, recreation, family healthy lifestyle, linkages to community resources, Families with low incomes, working poor, welfare recipients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- optimizing cost effectiveness for public systems
- the long-term effects on the health of low-income family members
- mechanisms that intervene between the interventions and their effect on the health of low-income family members
- building on previous research and on community-based initiatives
- promoting knowledge transfer
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Primary Health Care Model (PRMHLTH) |
| 2 | Experimental | Behavioral: Recreation Coordination Model (REC) |
| 3 | Experimental | Behavioral: Comprehensive Model (COMP) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Participant families will
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Health Care Model (PRMHLTH)Primary health care service delivery | Behavioural | 1 |
| Recreation Coordination Model (REC)Recreation coordination service delivery | Behavioural | 2 |
| Comprehensive Model (COMP)a comprehensive service delivery model consisting of PRMHLTH plus REC. | Behavioural | 3 |
Primary outcome
Increased linkages between low income families and established services in their communities
Time frame: Baseline, 12-month, 24-month, 36-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Background: PubMed 11762894Browne 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.
- Derived from this study: PubMed 27449358Drummond 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.
- Derived from this study: PubMed 24885729Drummond 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.
- Families First Edmonton HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Drummond, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary Health Care Model (PRMHLTH), Recreation Coordination Model (REC) and Comprehensive Model (COMP) in people with Low-Income Population, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased linkages between low income families and established services in their communities (time frame: Baseline, 12-month, 24-month, 36-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705328, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.