DiabetesEPICNCT00481286
Improving Outcomes Using Collaborative Group Clinics to Empower Older Patients
A study testing Improving outcomes using group clinics for older patients in people with Diabetes and Hypertension, run by Baylor College of Medicine.
Trial summary
The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Diabetes, Hypertension
- What is being tested?
- Improving outcomes using group clinics for older patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Sep 2009
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes and hypertension
- HgA1C value greater than or equal to 7.5
- Creatinine value less than or equal to 2.0mg/dl
- SBP greater than or equal to 140
Who cannot join
- Prior diagnoses of dementia using ICD-9 codes validated for a VA population
About this study
Official title: Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients
The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.
Read the detailed description
Among persons aged 55-84 years, over 65% have one to three common medical conditions (e.g., hypertension, diabetes, arthritis, stroke, heart disease, etc.). Fortunately, large randomized clinical trials have demonstrated the effectiveness of treatment and prevention strategies for many chronic conditions (e.g., dietary modification and medications for hypertension, intensive glucose monitoring with diet and medication regimens for diabetes, etc.). Despite the significant findings from numerous clinical trials, most older persons continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. Non-compliance with clinical guidelines by providers (i.e. clinical inertia) and non-adherence to doctors' recommendations are typically blamed for these unacceptably poor outcomes. For older adults with several conditions, the processes of patient-clinician collaboration are not well understood. Goal-setting behaviors may improve health care by linking desired outcomes (i.e., reduce risk of heart attacks) to the goals of care (i.e., salt restriction for hypertension control). Furthermore, the process of goal-setting may be more effective if patients internalize the importance of a particular goal and prioritize that goal among multiple clinical problems (i.e., hypertension care for patients with diabetes.
Effective methods of implementing collaborative goals and training patients to negotiate shared goals and goal-directed behaviors with their clinicians have been developed for diabetes control. The effectiveness of these methods may be enhanced through the use of clinics that enroll small groups of subjects with rapid follow-up for several weeks. Group clinics have demonstrated improved outcomes for common chronic conditions. Evidence demonstrating the synergistic benefit of efficient group clinics and collaborative goal-setting is limited. However, an approach combining these methodologies may provide an improved method of rapidly controlling multiple chronic conditions and maintaining control of those chronic conditions over a prolonged time period.
To address the gap in the implementation of effective and efficient medical care, we will develop and test a model of collaborative group clinics that empowers older patients to adopt goal-setting behaviors, increases communication with their health care provider, and improves their diabetes-related outcomes. The objectives are to use a collaborative group clinic to: 1) Improve diabetes process of care outcomes over a 3 month time period; 2) Significantly improve the maintenance of diabetes process of care improvements over a 12 month time period; and 3) Significantly improve use of self-management behaviors for diabetes care.
- Conditions
- Diabetes, Hypertension
- Being tested
- Improving outcomes using group clinics for older patients, Standard of Care
- Keywords
- Group clinics, Goal setting, Diabetes, Hypertension, Age 50+
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improving outcomes using group clinics for older patientsBehavioural
Also called Diabetes Group Clinic, Goal-setting Clinic
Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.
Standard of CareBehavioural
Also called Diabetes usual care
Standard of care for diabetes patients
| Study group | Role | What they receive |
|---|---|---|
| Group Clinic | Experimental | Patients in Group Clinic arm will meet every 3rd week for 12 weeks, for a total of 4 visits. At each visit, BP will be measured, home BP and glucose measurements collected. Each visit will include group-based education and feedback sessions, with an individualized process of selecting and modifying process of care goals for systolic BP, H1C, and LDL cholesterol. Short-term health behavior change goals will also be discussed. Receives: Behavioral: Improving outcomes using group clinics for older patients |
| Uusual Care | Placebo comparator | Older diabetes patients will attend regular clinician visits and one targeted primary care physician visit during the 12 weeks post-enrollment. They will be enrolled in a diabetes education class. Blood pressure, H1C and lipids will be measured at enrollment, 6 weeks , and 12 weeks. Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein
Change in systolic blood pressure; change in Hemoglobin A1C; change in low
Measured: 12 months
Secondary outcomes (1)
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic
Attainment of benchmark levels for SBP, A1C, LDL; self-management
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startApr 2007
- Primary completionApr 2008
- Study completionSep 2009
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 DiabetesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center, Michael E. DeBakey VA Medical Center
- Responsible party
- Principal investigator, Aanand Naik, Baylor College of Medicine
- Investigators
- Aanand D Naik, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481286
- Sponsor's protocol ID
- H-20437
- Other IDs
- 7U18HS016093
- Acronym
- EPIC
- Status last verified
- Oct 2009
- First submitted
- 31 May 2007
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Teal CR, Haidet P, Balasubramanyam AS, Rodriguez E, Naik AD. Measuring the quality of patients' goals and action plans: development and validation of a novel tool. BMC Med Inform Decis Mak. 2012 Dec 27;12:152. doi: 10.1186/1472-6947-12-152.
PubMed 23270422Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. Arch Intern Med. 2011 Mar 14;171(5):453-9. doi: 10.1001/archinternmed.2011.70.
PubMed 21403042
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Multiple Morbidities Using Collaborative Group Clinics to Empower Older Patients
- ClinicalTrials.gov ID
- NCT00481286
- Acronym / sponsor ID
- EPIC / H-20437
- Conditions
- Diabetes, Hypertension
- Keywords
- Group clinics, Goal setting, Diabetes, Hypertension, Age 50+
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), M.D. Anderson Cancer Center, Michael E. DeBakey VA Medical Center
- Study start
- Apr 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 1 Jun 2007 (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 determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.
Detailed description
Among persons aged 55-84 years, over 65% have one to three common medical conditions (e.g., hypertension, diabetes, arthritis, stroke, heart disease, etc.). Fortunately, large randomized clinical trials have demonstrated the effectiveness of treatment and prevention strategies for many chronic conditions (e.g., dietary modification and medications for hypertension, intensive glucose monitoring with diet and medication regimens for diabetes, etc.). Despite the significant findings from numerous clinical trials, most older persons continue to suffer from uncontrolled hypertension, hyperglycemia, and other predictors of poor health outcomes. Non-compliance with clinical guidelines by providers (i.e. clinical inertia) and non-adherence to doctors' recommendations are typically blamed for these unacceptably poor outcomes. For older adults with several conditions, the processes of patient-clinician collaboration are not well understood. Goal-setting behaviors may improve health care by linking desired outcomes (i.e., reduce risk of heart attacks) to the goals of care (i.e., salt restriction for hypertension control). Furthermore, the process of goal-setting may be more effective if patients internalize the importance of a particular goal and prioritize that goal among multiple clinical problems (i.e., hypertension care for patients with diabetes.
Effective methods of implementing collaborative goals and training patients to negotiate shared goals and goal-directed behaviors with their clinicians have been developed for diabetes control. The effectiveness of these methods may be enhanced through the use of clinics that enroll small groups of subjects with rapid follow-up for several weeks. Group clinics have demonstrated improved outcomes for common chronic conditions. Evidence demonstrating the synergistic benefit of efficient group clinics and collaborative goal-setting is limited. However, an approach combining these methodologies may provide an improved method of rapidly controlling multiple chronic conditions and maintaining control of those chronic conditions over a prolonged time period.
To address the gap in the implementation of effective and efficient medical care, we will develop and test a model of collaborative group clinics that empowers older patients to adopt goal-setting behaviors, increases communication with their health care provider, and improves their diabetes-related outcomes. The objectives are to use a collaborative group clinic to: 1) Improve diabetes process of care outcomes over a 3 month time period; 2) Significantly improve the maintenance of diabetes process of care improvements over a 12 month time period; and 3) Significantly improve use of self-management behaviors for diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Clinic | Experimental | Behavioral: Improving outcomes using group clinics for older patientsPatients in Group Clinic arm will meet every 3rd week for 12 weeks, for a total of 4 visits. At each visit, BP will be measured, home BP and glucose measurements collected. Each visit will include group-based education and feedback sessions, with an individualized process of selecting and modifying process of care goals for systolic BP, H1C, and LDL cholesterol. Short-term health behavior change goals will also be discussed. |
| Uusual Care | Placebo comparator | Behavioral: Standard of CareOlder diabetes patients will attend regular clinician visits and one targeted primary care physician visit during the 12 weeks post-enrollment. They will be enrolled in a diabetes education class. Blood pressure, H1C and lipids will be measured at enrollment, 6 weeks , and 12 weeks. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of diabetes and hypertension
- HgA1C value greater than or equal to 7.5
- Creatinine value less than or equal to 2.0mg/dl
- SBP greater than or equal to 140
Key exclusion criteria (1 listed)
- Prior diagnoses of dementia using ICD-9 codes validated for a VA population
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 |
|---|---|---|
| Improving outcomes using group clinics for older patientsAlso: Diabetes Group Clinic, Goal-setting ClinicCollaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes. | Behavioural | Group Clinic |
| Standard of CareAlso: Diabetes usual careStandard of care for diabetes patients | Behavioural | Uusual Care |
Primary outcome
Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein
Time frame: 12 months
Change in systolic blood pressure; change in Hemoglobin A1C; change in low
1 secondary outcome
Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic
Time frame: 12 months
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 2 Mar 2020.
- Derived from this study: PubMed 23270422Teal CR, Haidet P, Balasubramanyam AS, Rodriguez E, Naik AD. Measuring the quality of patients' goals and action plans: development and validation of a novel tool. BMC Med Inform Decis Mak. 2012 Dec 27;12:152. doi: 10.1186/1472-6947-12-152.
- Derived from this study: PubMed 21403042Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. Arch Intern Med. 2011 Mar 14;171(5):453-9. doi: 10.1001/archinternmed.2011.70.
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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.
Aanand D Naik, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Improving outcomes using group clinics for older patients in people with Diabetes and Hypertension, run by Baylor College of Medicine.
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 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 2 Mar 2020. 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. Some participants in this study may receive a placebo. 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 systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein (time frame: 12 months). 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 NCT00481286, 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 2 Mar 2020.