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

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ClinicalTrials.gov Identifier: NCT01920256
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Israel Hodish MD PhD, University of Michigan

Tracking Information
First Submitted Date  ICMJE August 2, 2013
First Posted Date  ICMJE August 9, 2013
Last Update Posted Date November 2, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
Change in baseline A1C (glycated hemoglobin) at 12 months [ Time Frame: 12 months ]
Measure of long-term blood glucose control and efficacy of intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01920256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2013)
  • Change in baseline lipids at 12 months [ Time Frame: 12 months ]
    Measure of total cholesterol, LDL, and Triglycerides
  • Change in baseline blood pressure at 12 months [ Time Frame: 12 months ]
    Systolic and diastolic blood pressure
  • All cause mortality [ Time Frame: 12 months ]
    Record deaths due to any cause
  • Acute complications [ Time Frame: 12 months ]
    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 ]
    Short Form-36
  • Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ]
    Insulin Therapy Satisfaction Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • Change in baseline lipids at 12 months [ Time Frame: 12 months ]
    Measure of total cholesterol, LDL, and Triglycerides
  • Change in baseline blood pressure at 12 months [ Time Frame: 12 months ]
    Systolic and diastolic blood pressure
  • All cause mortality [ Time Frame: 12 months ]
    Record deaths due to any cause
  • Acute complications [ Time Frame: 12 months ]
    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 ]
    Quality of Well-being Index
  • Change in baseline insulin satisfaction at 12 months [ Time Frame: 12 months ]
    Insulin Therapy Satisfaction Questionnaire
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2013)
  • Clinic retention [ Time Frame: 12 months ]
    Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
  • Cost [ Time Frame: 12 months ]
    Resource utilization and cost for both groups
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Official Title  ICMJE Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Other: Remote, personalized type 2 diabetes care.
    Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
  • Other: Usual Endocrine care.
    Diabetes and comorbidities management will provided by an endocrinologist
Study Arms  ICMJE
  • Experimental: Personalized type 2 diabetes care.
    Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
    Intervention: Other: Remote, personalized type 2 diabetes care.
  • Active Comparator: Usual Endocrine Care
    Usual Endocrine care will be provided by an endocrinologist.
    Intervention: Other: Usual Endocrine care.
Publications * Klingeman H, Funnell M, Jhand A, Lathkar-Pradhan S, Hodish I. Type 2 diabetes specialty clinic model for the accountable care organization era. J Diabetes Complications. 2017 Oct;31(10):1521-1526. doi: 10.1016/j.jdiacomp.2017.05.011. Epub 2017 May 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2013)
100
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01920256
Other Study ID Numbers  ICMJE UMichigan
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Experimental group patients informed of A1C results.
Responsible Party Israel Hodish MD PhD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Israel Hodish, MD, PhD University of Michigan
PRS Account University of Michigan
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP