Type 2 Diabetes MellitusFORGE AHEADNCT02234973
Transformation of Indigenous Primary Healthcare Delivery
An observational study of Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health outcomes compared to the general population because of a wide array of factors: social determinants of health, lifestyle, genetic susceptibility, and historic-political and psycho-social factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Quality Improvement
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to 31 Mar 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Indigenous community and clinic team members
Who may be able to join
- 18 years of age or older
- on-reserve residents of participating Indigenous community partners
- Health centers of participating Indigenous community partners
- Current type 2 diabetes mellitus registry and surveillance system
- adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%
Who cannot join
- less than 18 years of age
- off-reserve residents of participating or non-participating Indigenous community partners
- Clinic team members
- Health centers of non-participating Indigenous community partners
- No registry or surveillance system
- Diabetes Registry
- gestational diabetes, type 1 diabetes, or severe co-morbidity associated with life expectancy <6 months.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre for Studies in Family Medicine, Western University
London, Ontario, N6G2M1
About this study
Official title: Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits
Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health outcomes compared to the general population because of a wide array of factors: social determinants of health, lifestyle, genetic susceptibility, and historic-political and psycho-social factors. Barriers to care that are unique to First Nations communities exacerbate the problem with fragmented healthcare, poor chronic disease management, healthcare staff turnover, and limited, or non-existent, surveillance.
Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research program aims to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease prevention and management in First Nations communities in Canada. Participants will consist of Indigenous community and clinic team members that will take part in multiple interrelated projects including community profiling, readiness consultations, diabetes registry and surveillance, and quality improvement workshops and action periods.
Read more
Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical process and outcomes measures, 2) details about community-driven innovations, and 3) knowledge about the experience and cost of attempting to improve primary delivery in individual Indigenous communities.
Intervention/Instrument: Survey, literature review, 15 month intervention (readiness consultations, implementation and maintenance of a registry and surveillance system, community and clinic focused quality improvement workshops), interviews.
Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline); Secondary-clinical process and outcome measures, change in stage of readiness, description of participation and innovation facilitators and barriers.
Policy Implications: The outcomes of this research program have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities. Policy recommendations will be made to help support Indigenous communities in adopting successful innovations to help address issues related to diabetes and other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the subsequent policy decisions may enhance chronic disease prevention and management for Indigenous peoples across the country.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Quality Improvement
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality ImprovementBehavioural
Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.
| Study group | Role | What they receive |
|---|---|---|
| 11 First Nations Community and Clinical Teams | 11 Community \& Clinical Teams in each First Nation community participated in the intervention. Receives: Behavioral: Quality Improvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Measured: repeated measures: baseline (12 months prior to the start of the program)
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Measured: repeated measures: 6 month after program start date
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Measured: repeated measures: 12 month after program start date
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Measured: repeated measure: 18 months after program start
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Measured: repeated measure: 24 months after program start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2017
- Study completion31 Mar 2020
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 Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada, First Nation Community Partners, Health Canada, First Nations and Inuit Health Branch, Assembly of First Nations, Canadian Diabetes Association, Ontario Stroke Network, Heart and Stroke Foundation of Canada, Toronto Health Economics and Technology Assessment Collaborative, Tri-Ethnic Research Center Colorado State University, Hindsight Healthcare Strategies, AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Stewart B Harris, MD, MPH, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234973
- Sponsor's protocol ID
- 0000031372
- Acronym
- FORGE AHEAD
- Status last verified
- Feb 2020
- First submitted
- 30 Jul 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
Publications
Tompkins JW, Mequanint S, Barre DE, Fournie M, Green ME, Hanley AJ, Hayward MN, Zwarenstein M, Harris SB; FORGE AHEAD Program Team. National Survey of Indigenous primary healthcare capacity and delivery models in Canada: the TransFORmation of IndiGEnous PrimAry HEAlthcare delivery (FORGE AHEAD) community profile survey. BMC Health Serv Res. 2018 Nov 1;18(1):828. doi: 10.1186/s12913-018-3578-8.
PubMed 30382912Hayward MN, Mequanint S, Paquette-Warren J, Bailie R, Chirila A, Dyck R, Green M, Hanley A, Tompkins J, Harris S; FORGE AHEAD Program Team. The FORGE AHEAD clinical readiness consultation tool: a validated tool to assess clinical readiness for chronic disease care mobilization in Canada's First Nations. BMC Health Serv Res. 2017 Mar 23;17(1):233. doi: 10.1186/s12913-017-2175-6.
PubMed 28335823Naqshbandi Hayward M, Paquette-Warren J, Harris SB; FORGE AHEAD Program Team. Developing community-driven quality improvement initiatives to enhance chronic disease care in Indigenous communities in Canada: the FORGE AHEAD program protocol. Health Res Policy Syst. 2016 Jul 26;14(1):55. doi: 10.1186/s12961-016-0127-y.
PubMed 27456349
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD): Community-driven Innovations and Strategic Scale-up Toolkits
- ClinicalTrials.gov ID
- NCT02234973
- Acronym / sponsor ID
- FORGE AHEAD / 0000031372
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Western Ontario, Canada, First Nation Community Partners, Health Canada, First Nations and Inuit Health Branch, Assembly of First Nations, Canadian Diabetes Association, Ontario Stroke Network, Heart and Stroke Foundation of Canada, Toronto Health Economics and Technology Assessment Collaborative, Tri-Ethnic Research Center Colorado State University, Hindsight Healthcare Strategies, AstraZeneca
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Sep 2014 (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.
Context: Indigenous peoples experience higher prevalence rates of diabetes and worse health outcomes compared to the general population because of a wide array of factors: social determinants of health, lifestyle, genetic susceptibility, and historic-political and psycho-social factors. Barriers to care that are unique to First Nations communities exacerbate the problem with fragmented healthcare, poor chronic disease management, healthcare staff turnover, and limited, or non-existent, surveillance.
Program: The TransFORmation of IndiGEnous PrimAry HEAlthcare Delivery (FORGE AHEAD) research program aims to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease prevention and management in First Nations communities in Canada. Participants will consist of Indigenous community and clinic team members that will take part in multiple interrelated projects including community profiling, readiness consultations, diabetes registry and surveillance, and quality improvement workshops and action periods.
Design: This mixed-method pre-post observational study will capture: 1) diabetes clinical process and outcomes measures, 2) details about community-driven innovations, and 3) knowledge about the experience and cost of attempting to improve primary delivery in individual Indigenous communities.
Intervention/Instrument: Survey, literature review, 15 month intervention (readiness consultations, implementation and maintenance of a registry and surveillance system, community and clinic focused quality improvement workshops), interviews.
Measures: Primary- mean A1C of patients with diabetes (A1C ≥ 8.0% at baseline); Secondary-clinical process and outcome measures, change in stage of readiness, description of participation and innovation facilitators and barriers.
Policy Implications: The outcomes of this research program have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities. Policy recommendations will be made to help support Indigenous communities in adopting successful innovations to help address issues related to diabetes and other chronic illnesses. The community-driven innovations developed in FORGE AHEAD and the subsequent policy decisions may enhance chronic disease prevention and management for Indigenous peoples across the country.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 11 First Nations Community and Clinical Teams | – | Behavioral: Quality Improvement11 Community \& Clinical Teams in each First Nation community participated in the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Indigenous community and clinic team members
Key inclusion criteria (5 listed)
- 18 years of age or older
- on-reserve residents of participating Indigenous community partners
- Health centers of participating Indigenous community partners
- Current type 2 diabetes mellitus registry and surveillance system
- adults (age≥ 18 years) with type 2 diabetes and most recent HbA1C≥ 8.0%
Key exclusion criteria (7 listed)
- less than 18 years of age
- off-reserve residents of participating or non-participating Indigenous community partners
- Clinic team members
- Health centers of non-participating Indigenous community partners
- No registry or surveillance system
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 |
|---|---|---|
| Quality ImprovementCommunity and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic. | Behavioural | 11 First Nations Community and Clinical Teams |
Primary outcome
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Time frame: repeated measures: baseline (12 months prior to the start of the program)
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Time frame: repeated measures: 6 month after program start date
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Time frame: repeated measures: 12 month after program start date
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Time frame: repeated measure: 18 months after program start
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline)
Time frame: repeated measure: 24 months after program start
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 11 Jun 2020.
- Derived from this study: PubMed 30382912Tompkins JW, Mequanint S, Barre DE, Fournie M, Green ME, Hanley AJ, Hayward MN, Zwarenstein M, Harris SB; FORGE AHEAD Program Team. National Survey of Indigenous primary healthcare capacity and delivery models in Canada: the TransFORmation of IndiGEnous PrimAry HEAlthcare delivery (FORGE AHEAD) community profile survey. BMC Health Serv Res. 2018 Nov 1;18(1):828. doi: 10.1186/s12913-018-3578-8.
- Derived from this study: PubMed 28335823Hayward MN, Mequanint S, Paquette-Warren J, Bailie R, Chirila A, Dyck R, Green M, Hanley A, Tompkins J, Harris S; FORGE AHEAD Program Team. The FORGE AHEAD clinical readiness consultation tool: a validated tool to assess clinical readiness for chronic disease care mobilization in Canada's First Nations. BMC Health Serv Res. 2017 Mar 23;17(1):233. doi: 10.1186/s12913-017-2175-6.
- Derived from this study: PubMed 27456349Naqshbandi Hayward M, Paquette-Warren J, Harris SB; FORGE AHEAD Program Team. Developing community-driven quality improvement initiatives to enhance chronic disease care in Indigenous communities in Canada: the FORGE AHEAD program protocol. Health Res Policy Syst. 2016 Jul 26;14(1):55. doi: 10.1186/s12961-016-0127-y.
- Related InfoLink 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.
Stewart B Harris, MD, MPH principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 5 inclusion and 7 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 11 Jun 2020. 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.
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?
mean HbA1C of patients with diabetes (A1C ≥ 8.0% at baseline) (time frame: repeated measures: baseline (12 months prior to the start of the program)). The study lists 5 primary outcomes in all. 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 NCT02234973, 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 11 Jun 2020.