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

31. oktober 2018 opdateret af: Israel Hodish MD PhD, University of Michigan

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Health System

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Personalized type 2 diabetes care.
Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments.
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Aktiv komparator: Usual Endocrine Care
Usual Endocrine care will be provided by an endocrinologist.
Diabetes and comorbidities management will provided by an endocrinologist

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in baseline A1C (glycated hemoglobin) at 12 months
Tidsramme: 12 months
Measure of long-term blood glucose control and efficacy of intervention
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in baseline lipids at 12 months
Tidsramme: 12 months
Measure of total cholesterol, LDL, and Triglycerides
12 months
Change in baseline blood pressure at 12 months
Tidsramme: 12 months
Systolic and diastolic blood pressure
12 months
All cause mortality
Tidsramme: 12 months
Record deaths due to any cause
12 months
Acute complications
Tidsramme: 12 months
Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
12 months
Change in baseline Quality of life at 12 months
Tidsramme: 12 months
Short Form-36
12 months
Change in baseline insulin satisfaction at 12 months
Tidsramme: 12 months
Insulin Therapy Satisfaction Questionnaire
12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinic retention
Tidsramme: 12 months
Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
12 months
Cost
Tidsramme: 12 months
Resource utilization and cost for both groups
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Israel Hodish, MD, PhD, University of Michigan

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2013

Primær færdiggørelse (Faktiske)

1. marts 2016

Studieafslutning (Faktiske)

1. juni 2017

Datoer for studieregistrering

Først indsendt

2. august 2013

Først indsendt, der opfyldte QC-kriterier

7. august 2013

Først opslået (Skøn)

9. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Experimental group patients informed of A1C results.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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