Diabetes Mellitus, Type 2NCT01945918
Comparing Strategies for Translating Self-management Support Into Primary Care
A study testing Self-management support education, Connection to Health Interactive Behavior Change Technology and Connection to Health plus Coaching (CTH+C) in people with Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Self-management support education, Connection to Health Interactive Behavior Change Technology and Connection to Health plus Coaching (CTH+C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 31 Jul 2017
- Phase
- Interventional
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years old or over
- Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
- Able to read in English or Spanish
- Plan to remain in the practice during the study period
Who cannot join
- Developmentally disabled
- Decisionally challenged
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Aurora, Colorado, 80045
About this study
This project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.
Read the detailed description
The specific aims of the proposed study are:
- Primary Specific Aims
- To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.
- To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.
- Secondary Specific Aims
- To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.
- To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Self-management support education, Connection to Health Interactive Behavior Change Technology, Connection to Health plus Coaching (CTH+C)
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management support educationBehavioural
Same as Arm Description
Connection to Health Interactive Behavior Change TechnologyBehavioural
Same as Arm Description
Connection to Health plus Coaching (CTH+C)Behavioural
Same as Arm Description
| Study group | Role | What they receive |
|---|---|---|
| Self-management support education | Active comparator | Project staff will meet onsite with practice clinicians for a two-hour session to discuss what self-management support (SMS) is, why it is important, how primary care plays a role in this process, how others have approached it, and how it can be time and cost efficient for them to engage in SMS as part of standard diabetes care. Practices will have access to a website displaying general and local SMS resources. Discussion of the implementation of these resources into the practice will be facilitated. Two additional academic detailing visits will be made to check on progress on SMS adoption, provide additional information as needed, and answer questions. No input will be provided regarding how unique practice characteristics might be utilized for more effective implementation of SMS, and CTH will not be introduced. Receives: Behavioral: Self-management support education |
| Connection to Health Interactive Behavior Change Technology | Active comparator | Connection to Health (CTH) Arm: The number and length of staff visits to these practices will be the same as for the SMS Education Arm, but the content of the visits will center on the implementation and use of the CTH program as a way to implement SMS. Clinicians and selected staff members will be given hands-on experience using the system and will be provided with scenarios that will highlight the effective use of CTH as a tool for diabetes SMS. The practices will then implement CTH, using protocols selected from several suggested by the research team. Additional technical assistance with implementing CTH will also be provided as needed. Receives: Behavioral: Connection to Health Interactive Behavior Change Technology |
| Connection to Health plus Coaching | Experimental | Connection to Health plus Coaching (CTH+C) Arm: This arm adds practice coaching as described above to CTH. The active coaching phase focuses on meetings of the practice improvement team, scheduled every other week for approximately 40 minutes each. The improvement team will consist of 6 - 10 diverse representatives of the practice (e.g., front office, medical assistants, physicians). The coach will assist the team in developing a CTH adoption plan and then help them break it down into small bites for rapid cycle change using the Plan-Do-Study-Act quality improvement (QI) model. Active coaching will last for 3 months, followed by monthly calls by the coach to review data regarding the practice's use of CTH and brief "booster" coaching to deal with problems. Receives: Behavioral: Connection to Health Interactive Behavior Change Technology; Behavioral: Connection to Health plus Coaching (CTH+C) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c from baseline to 18 months
Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.
Measured: 18 months from baseline
Change in LDL from baseline to 18 months
Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).
Measured: 18 months from baseline
Change in systolic and diastolic blood pressure from baseline to 18 months
Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)
Measured: 18 months from baseline
Change in body mass index (BMI) from baseline to 18 months
Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / [height (m)]2; e.g., 24.96)
Measured: 18 months from baseline
Secondary outcomes (1)
Evidence of documented self-management support for patients through medical record review
The following elements will be assessed in medical record review: presence of a personal care plan with regular updating, evidence of collaborative goal setting, evidence of action planning around prioritized patient goals, evidence of collaborative problem-solving regarding the action planning process, use of community resources to assist in goal attainment, and evidence of ongoing monitoring of progress on identified goals. A total score will be the sum of positive elements.
Measured: 18 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startOct 2013
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- W. Perry Dickinson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945918
- Sponsor's protocol ID
- 12-0645
- Other IDs
- 1R18DK096387-01
- Status last verified
- Dec 2017
- First submitted
- 27 Aug 2013
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hessler DM, Fisher L, Bowyer V, Dickinson LM, Jortberg BT, Kwan B, Fernald DH, Simpson M, Dickinson WP. Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection. BMC Fam Pract. 2019 Aug 29;20(1):120. doi: 10.1186/s12875-019-1012-x.
PubMed 31464589Dickinson WP, Dickinson LM, Jortberg BT, Hessler DM, Fernald DH, Fisher L. A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices. BMC Fam Pract. 2018 Jul 24;19(1):126. doi: 10.1186/s12875-018-0810-x.
PubMed 30041598
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Strategies for Translating Self-management Support Into Primary Care
- ClinicalTrials.gov ID
- NCT01945918
- Acronym / sponsor ID
- 12-0645
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Primary Health Care, Self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2013 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 19 Sep 2013 (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 project will test different ways of helping primary care practices to do a better job of self-management support (SMS) for their patients with diabetes.
Detailed description
The specific aims of the proposed study are:
- Primary Specific Aims
- To conduct a cluster randomized trial to examine the reach, effectiveness, adoption, implementation and maintenance (RE-AIM) of Connection to Health (CTH) for patients with type 2 diabetes in primary care practice settings. Primary effectiveness outcomes will include hemoglobin A1c, Body Mass Index (BMI), blood pressure and Low Desity Lipprotein (LDL) cholesterol.
- To determine the incremental benefit, using the RE-AIM framework, of brief targeted practice coaching on the implementation of CTH in diverse primary care practices.
- Secondary Specific Aims
- To identify key practice characteristics (e.g., practice size, organization, setting, and level of experience with practice redesign efforts) that impact CTH RE-AIM. These results will inform dissemination of the CTH intervention.
- To determine the relative costs associated with implementing CTH and practice coaching to further inform dissemination efforts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Self-management support education | Active comparator | Behavioral: Self-management support educationProject staff will meet onsite with practice clinicians for a two-hour session to discuss what self-management support (SMS) is, why it is important, how primary care plays a role in this process, how others have approached it, and how it can be time and cost efficient for them to engage in SMS as part of standard diabetes care. Practices will have access to a website displaying general and local SMS resources. Discussion of the implementation of these resources into the practice will be facilitated. Two additional academic detailing visits will be made to check on progress on SMS adoption, provide additional information as needed, and answer questions. No input will be provided regarding how unique practice characteristics might be utilized for more effective implementation of SMS, and CTH will not be introduced. |
| Connection to Health Interactive Behavior Change Technology | Active comparator | Behavioral: Connection to Health Interactive Behavior Change TechnologyConnection to Health (CTH) Arm: The number and length of staff visits to these practices will be the same as for the SMS Education Arm, but the content of the visits will center on the implementation and use of the CTH program as a way to implement SMS. Clinicians and selected staff members will be given hands-on experience using the system and will be provided with scenarios that will highlight the effective use of CTH as a tool for diabetes SMS. The practices will then implement CTH, using protocols selected from several suggested by the research team. Additional technical assistance with implementing CTH will also be provided as needed. |
| Connection to Health plus Coaching | Experimental | Behavioral: Connection to Health Interactive Behavior Change Technology, Behavioral: Connection to Health plus Coaching (CTH+C)Connection to Health plus Coaching (CTH+C) Arm: This arm adds practice coaching as described above to CTH. The active coaching phase focuses on meetings of the practice improvement team, scheduled every other week for approximately 40 minutes each. The improvement team will consist of 6 - 10 diverse representatives of the practice (e.g., front office, medical assistants, physicians). The coach will assist the team in developing a CTH adoption plan and then help them break it down into small bites for rapid cycle change using the Plan-Do-Study-Act quality improvement (QI) model. Active coaching will last for 3 months, followed by monthly calls by the coach to review data regarding the practice's use of CTH and brief "booster" coaching to deal with problems. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years old or over
- Type 2 Diabetes Mellitus diagnosed for a minimum of 12 months
- Able to read in English or Spanish
- Plan to remain in the practice during the study period
Key exclusion criteria (3 listed)
- Developmentally disabled
- Decisionally challenged
- Pregnant women
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 |
|---|---|---|
| Self-management support educationSame as Arm Description | Behavioural | Self-management support education |
| Connection to Health Interactive Behavior Change TechnologySame as Arm Description | Behavioural | Connection to Health Interactive Behavior Change Technology, Connection to Health plus Coaching |
| Connection to Health plus Coaching (CTH+C)Same as Arm Description | Behavioural | Connection to Health plus Coaching |
Primary outcome
Change in HbA1c from baseline to 18 months
Time frame: 18 months from baseline
Glycosylated hemoglobin (HbA1c) will be measured at baseline and 18 months from baseline.
Change in LDL from baseline to 18 months
Time frame: 18 months from baseline
Low-density lipoprotein (LDL) cholesterol will be measured at baseline and 18 months from baseline (in mg/dL; e.g., 160 mg/dL).
Change in systolic and diastolic blood pressure from baseline to 18 months
Time frame: 18 months from baseline
Systolic and diastolic blood pressure will be measured at baseline and 18 months from baseline (in mmHg; e.g., 140/90 mmHg)
Change in body mass index (BMI) from baseline to 18 months
Time frame: 18 months from baseline
Body mass index (BMI) will be measured at baseline and 18 months from baseline (weight (kg) / [height (m)]2; e.g., 24.96)
1 secondary outcome
Evidence of documented self-management support for patients through medical record review
Time frame: 18 months from baseline
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 20 Dec 2017.
- Derived from this study: PubMed 31464589Hessler DM, Fisher L, Bowyer V, Dickinson LM, Jortberg BT, Kwan B, Fernald DH, Simpson M, Dickinson WP. Self-management support for chronic disease in primary care: frequency of patient self-management problems and patient reported priorities, and alignment with ultimate behavior goal selection. BMC Fam Pract. 2019 Aug 29;20(1):120. doi: 10.1186/s12875-019-1012-x.
- Derived from this study: PubMed 30041598Dickinson WP, Dickinson LM, Jortberg BT, Hessler DM, Fernald DH, Fisher L. A protocol for a cluster randomized trial comparing strategies for translating self-management support into primary care practices. BMC Fam Pract. 2018 Jul 24;19(1):126. doi: 10.1186/s12875-018-0810-x.
Related trials for Diabetes Mellitus, Type 2
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
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.
W. Perry Dickinson, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management support education, Connection to Health Interactive Behavior Change Technology and Connection to Health plus Coaching (CTH+C) in people with Diabetes Mellitus, Type 2, run by University of Colorado, Denver at 1 site in United States.
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 4 inclusion and 3 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 20 Dec 2017. 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 United States. 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?
Change in HbA1c from baseline to 18 months (time frame: 18 months from baseline). The study lists 4 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 NCT01945918, which also lists 2 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 20 Dec 2017; AzTrials last refreshed its copy on 31 Oct 2026.