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Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Israel Hodish MD PhD, University of Michigan
ClinicalTrials.gov Identifier:
NCT01920256
First received: August 2, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.

Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.


Condition Intervention
Type 2 Diabetes
Other: Remote, personalized type 2 diabetes care.
Other: Usual Endocrine care.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change in baseline A1C (glycated hemoglobin) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Measure of long-term blood glucose control and efficacy of intervention


Secondary Outcome Measures:
  • Change in baseline lipids at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Measure of total cholesterol, LDL, and Triglycerides

  • Change in baseline blood pressure at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure

  • All cause mortality [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Record deaths due to any cause

  • Acute complications [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits

  • Change in baseline Quality of life at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Short Form-36

  • Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Insulin Therapy Satisfaction Questionnaire


Other Outcome Measures:
  • Clinic retention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups

  • Cost [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Resource utilization and cost for both groups


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
Other: Remote, personalized type 2 diabetes care.
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Active Comparator: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
Other: Usual Endocrine care.
Diabetes and comorbidities management will provided by an endocrinologist

Detailed Description:

Emerging data suggests that clinical interventions may be implemented successfully by a variety of remote communications. Thus far regular monitoring and treatment adjustments by remote communications have not yet been fully integrated into endocrine practice in a scalable fashion that can be readily disseminated. The PI proposes to test a new endocrine model care clinic for high-risk patients with type 2 diabetes that employs regular communications initiated by the provider, based on a tailored individual plan. Frequent monitoring and interventions will reinforce attainment of prespecified therapy goals, enhance patient engagement, and allow a significant decrease in the frequency of outpatient visits. In turn, the clinic will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. Data management and day-to-day clinic operation will be computerized with technology that has been developed by the institution. The project is highly significant since it proposes a new model of endocrine care for high-risk patients with type 2 diabetes that may improved disease outcome in more patients and reduce medical expenses.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged ≥18 years of age;
  • Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
  • Treated with insulin or at least two diabetes medications;
  • Have A1C ≥8.0% and ≤11.0%;
  • Able and willing to use telephone or other sorts of communication regularly between clinic visits.

Exclusion Criteria:

  • Do not speak English;
  • Unwilling or unable to provide informed consent;
  • Have any condition associated with life expectancy of less than 3 years;
  • Have an active mental illness or substance abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920256

Contacts
Contact: Israel Hodish, MD, PhD (734) 936-5505 ihodish@umich.edu
Contact: Martha Funnell, MS, RN, CDE (734) 936-9237 mfunnell@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Martha M Funnell, RN    734-936-9237    mfunnell@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Israel Hodish, MD, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Israel Hodish MD PhD, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01920256     History of Changes
Other Study ID Numbers: UMichigan
Study First Received: August 2, 2013
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Insulin therapy
Type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 26, 2014