Diabetes MellitusNCT01553266
Mobile Diabetes Education Teams in Primary Care
An observational study of Diabetes Mellitus, run by Toronto Metropolitan University.
Trial summary
The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's effectiveness in improving patient clinical and care process outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Mobile Diabetes Education Teams intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 900 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2012to 12 Apr 2017
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Those living with diabetes
Who may be able to join
- Has Diabetes Mellitus, Type 2;
- Is 18 years of age or older;
- Has an HbA1c of > 8%.
Who cannot join
- Has type of diabetes that requires intense and specialized treatment, such as Type 1 diabetes, gestational diabetes, or patients on a multiple, daily insulin regime.
About this study
The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's effectiveness in improving patient clinical and care process outcomes.
The study's hypotheses are that the MDET intervention results in the following outcomes:
- Improvement in patient clinical outcomes;
- An increase in the proportion of primary care physicians (PCPs) performing patient care processes according to clinical practice guidelines;
- An increase in the proportion of referrals to, and patients' utilization of, diabetes education programs (DEPs).
Read the detailed description
The proposed research is the first evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in Canada. This intervention will support primary care providers (PCPs) by offering a diabetes education team (one registered nurse [RN] and one registered dietitian [RD]) one to four times a month, based on patient volume, at various primary care sites to assist in and share the care and management of patients with diabetes. This intervention is in collaboration with the Mississauga Halton Local Health Integration Network (MH LHIN) and will be hosted by Trillium Diabetes Management Centre and Halton Diabetes Program. Each hosting site received permanent operational funding for half a diabetes education team (salary support) from the Ontario Ministry of Health and Long-term Care (MHLTC) under the new Ontario Diabetes Strategy.
The rationale for incorporating MDETs in primary care was guided by the extensive literature on the underuse and low referral to diabetes education programs (DEPs), where diabetes self-management education is primarily offered. Low utilization is due to low PCP referral rates to these services, as well as numerous systematic and operational barriers for both PCPs and patients. Consequently, the majority of Canadians are receiving diabetes care solely from their PCPs, who have expressed barriers to caring for diabetes patients and are providing sub-optimal care as they are not consistently adhering to clinical practice guidelines. As a result, MHLTC is investing millions of dollars in expanding and aligning current programs to increase access to team-based care.
The objective of this research is to evaluate a structural redesign in how the investigators deliver diabetes care and self-management education using a collaborative approach between PCPs and DEPs guided by the Chronic Care Model as a conceptual framework. The purpose of this research is twofold: 1) to evaluate the effects of MDET intervention on: (i) patient clinical outcomes; (ii) quality of care patients receive from PCPs; (iii) PCPs' referral to and their patients' utilization of DEPs; and 2) to assess the implementation processes of the MDET intervention and the degree of collaboration and team functioning between PCPs and the MDET members across primary care sites. A mixed-methods approach is proposed over a three year period.
Patients will be referred to the MDET by PCPs. The MDET will meet with patients for two hours (one hour with the RN and one hour with the RD) to assess the level of diabetes knowledge, diabetes self-care and lifestyle habits; this data will be used to develop patient treatment priorities and action care plans. Three 30 minute follow-up visits with the MDET will be carried out over a one-year period for all patients where patient action plans are reviewed, discussed and potentially revised. A communication tool has been developed to better facilitate communication of patient information between PCPs and MDETs. Case conferences will be conducted when major changes are to be made to the patient's treatment plan after a patient's visit. Accordingly, PCPs and educators are collaboratively managing patient care.
A cluster-randomized trial stepped wedge design will be used to ensure all sites will eventually receive the intervention, while still facilitating the comparison of change within individuals and between study groups across time points that is attributed to the intervention. The inclusion criteria for reviewing patient medical records are patients who are over 18 years of age, have type 2 diabetes, and have an HbA1c of greater than 8%. Twenty unique patient chart extractions will be performed at 0, 6, 12, 18, 24 months from 12 primary care sites to collect patient care processes and patient clinical outcome data (for a total of 1,200 patient charts). Characteristics of interprofessional collaboration between PCPs and the MDET will be assessed at each practice site at the end of one year. To assess the implementation of the MDET across sites, qualitative process data, such as in-depth interviews with patients, PCPs and the MDETs, and MDETs' field notes and debriefing sessions will be analyzed.
MDETs will strengthen and formalize links between primary care providers and diabetes education programs within the community, increase patient access to diabetes self-management education and support, and potentially improve patient experience and clinical outcomes through enhanced coordination and integration of care. This study is timely and relevant as DEPs and local PCPs are starting to integrate services across Canada; thus, our research will provide the evidence necessary to inform practice of such a model. If results are promising, this model can be extended to direct how those with impaired glucose tolerance and gestational diabetes/post-gestational diabetes; and as a result, diabetes prevention, management and care are delivered, and can greatly reduce the burden of diabetes in Canada.
- Conditions
- Diabetes Mellitus
- Being tested
- Mobile Diabetes Education Teams intervention
- Keywords
- Diabetes Mellitus, diabetes care, diabetes self-management education, primary care physicians, interprofessional collaboration, diabetes education programs, qualitative, quantitative, implementation, evaluation, health services, coordinated care, integrated care, patient care processes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Diabetes Education Teams interventionBehavioural
Also called MDET
A MDET (one Registered Nurse and Registered Dietician) supports primary care physicians by providing diabetes management education to the PCPs' patients onsite, one to four times a month based on patient volume.
| Study group | Role | What they receive |
|---|---|---|
| MDET intervention | Not described Receives: Behavioral: Mobile Diabetes Education Teams intervention | |
| Control group | Patients who have not received the MDET intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention
Change in patients' results for HbA1c from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Secondary outcomes (18)
Change from 12 months prior to intervention in low-density lipoprotein (LDL-C) up to 12 months during the intervention
Change in patients' results for low-density lipoprotein (LDL-C) from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in total cholesterol-high density lipoprotein ratio (TC-HDL ratio) up to 12 months during the intervention
Change in patients' results for total cholesterol-high density lipoprotein ratio (TC-HDL ratio) from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in blood pressure up to 12 months during the intervention
Change in patients' results for blood pressure from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in testing for HbA1c up to 12 months during the intervention
Change in proportion of primary care physicians testing for patients' HbA1c from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in blood pressure testing up to 12 months during the intervention
Change in proportion of primary care physicians testing for patients' blood pressure from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in lipid profile testing up to 12 months during the intervention
Change in proportion of primary care physicians testing for patients' lipid profile from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in nephropathy screening up to 12 months during the intervention
Change in proportion of primary care physicians screening patients for nephropathy (ACR and eGFR) from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in foot exams up to 12 months during the intervention
Change in proportion of primary care physicians performing foot exams from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in dilated retinal exam referrals up to 12 months during the intervention
Change in proportion of primary care physicians referring patients to dilated retinal exams from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in flu vaccine provision or recommendation up to 12 months during the intervention
Change in proportion of primary care physicians providing for, or recommending, the flu vaccine to patients from 12 months prior to intervention up to 12 months during the intervention.
Measured: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in Diabetes Education Program referrals at 12 months of intervention
Change in primary care physicians' referrals to, and patients' utilization of, diabetes education programs from 12 months prior to the intervention at 12 months of the intervention.
Measured: 12 months prior to intervention to 12 months of the intervention
Patient attendance at scheduled MDET visits
Number of MDET appointments planned for each patient compared to the number of MDET visits attended.
Measured: At 12 months of intervention
Collaborative Practice Assessment Tool scores of PCPs and MDET educators in intervention
Collaborative Practice Assessment Tool scores of PCPs and MDET educators at 12 months of the intervention, to assess interprofessional collaboration between PCPs and educators.
Measured: At 12 months of intervention
Patients' interview responses regarding intervention effectiveness
In-depth interview responses of 20 randomly-selected patients at 12 months of the intervention, regarding the usefulness of the intervention in better understanding their condition, diabetes self-management strategies, and convenience and quality of delivery.
Measured: At 12 months of intervention
PCPs' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
In-depth interview responses of 16 randomly-selected PCPs at 12 months of the intervention, regarding their experiences with the intervention, their collaboration and teamwork, barriers and facilitators to implementation, and suggestions to improve the intervention.
Measured: At 12 months of intervention
MDET educators' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
In-depth interview responses of 16 randomly-selected educators at 12 months of the intervention, regarding their experiences with the intervention, their collaboration and teamwork, barriers and facilitators to implementation, and suggestions to improve the intervention.
Measured: At 12 months of intervention
MDET educators' reflective journal responses regarding interprofessional collaboration in, and the implementation of, the intervention
MDET educators' monthly field notes in their reflective journals regarding their experiences and reflections of those experiences with the implementation of, and interprofessional collaboration in, the intervention.
Measured: Up to 2 years
MDET educators' quarterly debriefing session group discussions regarding intervention issues
MDET educators' group discussions during MDET debriefing sessions, held quarterly, regarding any issues with the implementation of the intervention.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study start1 Mar 2012
- Primary completion12 Mar 2014
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Trillium Health Centre
- Responsible party
- Principal investigator, Enza Gucciardi, Toronto Metropolitan University
- Investigators
- Enza Gucciardi, PhD, Principal investigator, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553266
- Sponsor's protocol ID
- REB 2010-282
- Other IDs
- 247888
- Status last verified
- Dec 2013
- First submitted
- 29 Feb 2012
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gucciardi E, Fortugno M, Horodezny S, Lou W, Sidani S, Espin S, Webster F, Shah BR. Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial. Trials. 2012 Sep 13;13:165. doi: 10.1186/1745-6215-13-165.
PubMed 22974080
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Diabetes Education Teams in Primary Care
- ClinicalTrials.gov ID
- NCT01553266
- Acronym / sponsor ID
- REB 2010-282
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, diabetes care, diabetes self-management education, primary care physicians, interprofessional collaboration, diabetes education programs, qualitative, quantitative
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Trillium Health Centre
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 12 Mar 2014 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 14 Mar 2012 (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.
The purpose of this study is to evaluate the implementation of the Mobile Diabetes Education Team (MDET) intervention in the Greater Toronto Area, as well as the intervention's effectiveness in improving patient clinical and care process outcomes.
The study's hypotheses are that the MDET intervention results in the following outcomes:
- Improvement in patient clinical outcomes;
- An increase in the proportion of primary care physicians (PCPs) performing patient care processes according to clinical practice guidelines;
- An increase in the proportion of referrals to, and patients' utilization of, diabetes education programs (DEPs).
Detailed description
The proposed research is the first evaluation of the implementation of Mobile Diabetes Education Teams (MDETs) in Canada. This intervention will support primary care providers (PCPs) by offering a diabetes education team (one registered nurse [RN] and one registered dietitian [RD]) one to four times a month, based on patient volume, at various primary care sites to assist in and share the care and management of patients with diabetes. This intervention is in collaboration with the Mississauga Halton Local Health Integration Network (MH LHIN) and will be hosted by Trillium Diabetes Management Centre and Halton Diabetes Program. Each hosting site received permanent operational funding for half a diabetes education team (salary support) from the Ontario Ministry of Health and Long-term Care (MHLTC) under the new Ontario Diabetes Strategy.
The rationale for incorporating MDETs in primary care was guided by the extensive literature on the underuse and low referral to diabetes education programs (DEPs), where diabetes self-management education is primarily offered. Low utilization is due to low PCP referral rates to these services, as well as numerous systematic and operational barriers for both PCPs and patients. Consequently, the majority of Canadians are receiving diabetes care solely from their PCPs, who have expressed barriers to caring for diabetes patients and are providing sub-optimal care as they are not consistently adhering to clinical practice guidelines. As a result, MHLTC is investing millions of dollars in expanding and aligning current programs to increase access to team-based care.
The objective of this research is to evaluate a structural redesign in how the investigators deliver diabetes care and self-management education using a collaborative approach between PCPs and DEPs guided by the Chronic Care Model as a conceptual framework. The purpose of this research is twofold: 1) to evaluate the effects of MDET intervention on: (i) patient clinical outcomes; (ii) quality of care patients receive from PCPs; (iii) PCPs' referral to and their patients' utilization of DEPs; and 2) to assess the implementation processes of the MDET intervention and the degree of collaboration and team functioning between PCPs and the MDET members across primary care sites. A mixed-methods approach is proposed over a three year period.
Patients will be referred to the MDET by PCPs. The MDET will meet with patients for two hours (one hour with the RN and one hour with the RD) to assess the level of diabetes knowledge, diabetes self-care and lifestyle habits; this data will be used to develop patient treatment priorities and action care plans. Three 30 minute follow-up visits with the MDET will be carried out over a one-year period for all patients where patient action plans are reviewed, discussed and potentially revised. A communication tool has been developed to better facilitate communication of patient information between PCPs and MDETs. Case conferences will be conducted when major changes are to be made to the patient's treatment plan after a patient's visit. Accordingly, PCPs and educators are collaboratively managing patient care.
A cluster-randomized trial stepped wedge design will be used to ensure all sites will eventually receive the intervention, while still facilitating the comparison of change within individuals and between study groups across time points that is attributed to the intervention. The inclusion criteria for reviewing patient medical records are patients who are over 18 years of age, have type 2 diabetes, and have an HbA1c of greater than 8%. Twenty unique patient chart extractions will be performed at 0, 6, 12, 18, 24 months from 12 primary care sites to collect patient care processes and patient clinical outcome data (for a total of 1,200 patient charts). Characteristics of interprofessional collaboration between PCPs and the MDET will be assessed at each practice site at the end of one year. To assess the implementation of the MDET across sites, qualitative process data, such as in-depth interviews with patients, PCPs and the MDETs, and MDETs' field notes and debriefing sessions will be analyzed.
MDETs will strengthen and formalize links between primary care providers and diabetes education programs within the community, increase patient access to diabetes self-management education and support, and potentially improve patient experience and clinical outcomes through enhanced coordination and integration of care. This study is timely and relevant as DEPs and local PCPs are starting to integrate services across Canada; thus, our research will provide the evidence necessary to inform practice of such a model. If results are promising, this model can be extended to direct how those with impaired glucose tolerance and gestational diabetes/post-gestational diabetes; and as a result, diabetes prevention, management and care are delivered, and can greatly reduce the burden of diabetes in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDET intervention | – | Behavioral: Mobile Diabetes Education Teams intervention |
| Control group | – | –Patients who have not received the MDET intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those living with diabetes
Key inclusion criteria (3 listed)
- Has Diabetes Mellitus, Type 2;
- Is 18 years of age or older;
- Has an HbA1c of > 8%.
Key exclusion criteria (1 listed)
- Has type of diabetes that requires intense and specialized treatment, such as Type 1 diabetes, gestational diabetes, or patients on a multiple, daily insulin regime.
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 |
|---|---|---|
| Mobile Diabetes Education Teams interventionAlso: MDETA MDET (one Registered Nurse and Registered Dietician) supports primary care physicians by providing diabetes management education to the PCPs' patients onsite, one to four times a month based on patient volume. | Behavioural | MDET intervention |
Primary outcome
Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change in patients' results for HbA1c from 12 months prior to intervention up to 12 months during the intervention.
18 secondary outcomes
Change from 12 months prior to intervention in low-density lipoprotein (LDL-C) up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in total cholesterol-high density lipoprotein ratio (TC-HDL ratio) up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in blood pressure up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in testing for HbA1c up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in blood pressure testing up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in lipid profile testing up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in nephropathy screening up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in foot exams up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in dilated retinal exam referrals up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in flu vaccine provision or recommendation up to 12 months during the intervention
Time frame: At 12 months prior to intervention; up to 12 months during the intervention
Change from 12 months prior to intervention in Diabetes Education Program referrals at 12 months of intervention
Time frame: 12 months prior to intervention to 12 months of the intervention
Patient attendance at scheduled MDET visits
Time frame: At 12 months of intervention
Collaborative Practice Assessment Tool scores of PCPs and MDET educators in intervention
Time frame: At 12 months of intervention
Patients' interview responses regarding intervention effectiveness
Time frame: At 12 months of intervention
PCPs' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
Time frame: At 12 months of intervention
MDET educators' interview responses regarding interprofessional collaboration in, and the implementation of, the intervention
Time frame: At 12 months of intervention
MDET educators' reflective journal responses regarding interprofessional collaboration in, and the implementation of, the intervention
Time frame: Up to 2 years
MDET educators' quarterly debriefing session group discussions regarding intervention issues
Time frame: Up to 2 years
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 18 Apr 2017.
- Derived from this study: PubMed 22974080Gucciardi E, Fortugno M, Horodezny S, Lou W, Sidani S, Espin S, Webster F, Shah BR. Will Mobile Diabetes Education Teams (MDETs) in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial. Trials. 2012 Sep 13;13:165. doi: 10.1186/1745-6215-13-165.
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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.
Enza Gucciardi, PhD principal investigator
Toronto Metropolitan University
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Toronto Metropolitan University.
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 3 inclusion and 1 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from 12 months prior to intervention in HbA1c up to 12 months during the intervention (time frame: At 12 months prior to intervention; up to 12 months during the intervention). 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 NCT01553266, which also lists 1 linked publication.
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 18 Apr 2017.