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Pilot of Virtual Health Coaching Utilizing Lifestyle for Under-Resourced Patients With Type II Diabetes

3 mai 2021 mis à jour par: Kimberly R Azelton, Beacon Health System
Accessible and effective interventions for chronic diseases such as diabetes are especially needed in the under-resourced patient population. This is a pilot randomized control trial compares usual diabetic care to usual diabetic care plus virtual health coaching utilizing lifestyle action plans in under-resourced adult type II diabetic patients. This is a one-site study at an under-resourced family medicine residency clinic. The primary outcome is the change of insulin resistance as measured by HOMA2-IR. Secondary metabolic outcomes are being tracked. Potentially confounding variables related to SDoH, race, and engagement in health coaching are being assessed for. The cost of the intervention as well as expensive healthcare utilization as measured by ER visits are also being tracked.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

Those having difficulty with SDoH (Social Determinants of Health) are associated with a higher incidence of diabetes as well as worse health outcomes. Inexpensive, effective virtual options for chronic diseases conducive to all levels of socio-economic status would be very beneficial. As early as 1934 there have been reports of nutritional interventions preventing and reversing DMII. A recent randomised trial utilizing meal replacement and caloric restriction noted greater diabetes remission rates with greater weight loss. Despite knowledge that weight and dietary factors are at the foundation of DMII incidence, control and even remission, it is challenging to find accessible, effective, community-based interventions.

Culturally sensitive health coaches trained to use motivational interviewing to create specific, measurable, attainable, reasonable and time-bound (S.M.A.R.T.) action plans through shared-decision making and thus personalized to the patients' literacy, resources and motivation level may overcome some of these cultural and literacy barriers. Accessibility is further increased by utilizing phone and text. This allows for low-tech, inexpensive remote patient monitoring. This real-time feedback may further increase patient self-efficacy and engagement. While using health coaching methods may improve diabetic control, the exact content of what should be delivered is unexplored. The mixed results of diabetes remission rates in dietary intervention studies is attributed to delivery of too low a "therapeutic dose" of lifestyle change. Therefore, it is postulated that health coaches personalizing the behavioral interventions that may be most effective in controlling and reversing diabetes may improve insulin resistance in a real-world primary-care based setting to those most challenged by barriers to care.

This is a pilot randomized control trial comparing usual care to usual care plus virtual health coaching utilizing lifestyle action plans in adult type II diabetic patients. This is a one-site study at an under-resourced family medicine residency clinic. The primary outcome is the change of insulin resistance as measured by HOMA2-IR. Secondary metabolic outcomes are being tracked. Potentially confounding variables related to SDoH, race, and engagement in health coaching are being assessed for. The cost of the intervention as well as expensive healthcare utilization as measured by ER visits are also being tracked.

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Indiana
      • South Bend, Indiana, États-Unis, 46601
        • Beacon Health System

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Diabetes (Hemoglobin A1C 6.5% or higher in the last year) who are regular patients of E. Blair Warner Clinic. English or Spanish speaking patients will be included who are between 18 and 65 years old with a working phone. Subjects recently started on or taking a short dose of medications that are known to influence insulin resistance (i.e. atypical antipsychotics, steroids, thiazides). Subjects (and their providers) on chronic doses of these medications will be asked to keep the dose the same.

Exclusion Criteria:

  • Patients whose preferred language is not English or Spanish will be excluded due to lack of health coaches speaking other languages. Approximately 50% of C-peptide is cleared by the kidney and some studies excluded advanced renal failure. For our study subjects with chronic renal failure with a GFR <45 on most recent blood work will be excluded. Subjects with conditions known to influence insulin resistance (i.e. pregnancy, hemochromatosis, polytransfused individuals) will be excluded. Subjects with syndromic obesity (i.e. hypothalamic obesity, pradi-willi syndrome) or type I diabetes mellitus will be excluded. Subjects with diagnosed diseases that would hinder giving consent or participating in health coaching (i.e. dementia, cognitive impairment) will be excluded. Subjects who have attended an intensive lifestyle change program and/or made an impacting lifestyle change in the last 3 months, such as losing 5% or more of their body weight in the last 3 months will also be excluded.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Usual Diabetic Care
Usual diabetic care for this study will include a diabetic visit with their primary care provider at the beginning and end of the 12 weeks. They will also be asked to continue their current level of physical activity and eating habits.
Expérimental: Usual Diabetic Care Plus Virtual Health Coaching
For the duration of the 12 weeks, Healthy at Home will provide health coaching in 10-20 minute phone calls weekly. They will request daily blood glucose logs as this is part of Healthy at Home's normal procedure. The health coach and subject will choose a patient-directed overarching goal such as "lose weight," or improve my blood sugar numbers," etc. that the health coach will then help the patient turn into a SMART goal. They will do this by utilizing a list of lifestyle change categories as top priority goals from which to choose from in their patient-directed health coaching sessions. Texting will be utilized to request daily blood glucose and provide real-time coaching via text.
Comportemental: Phone-Based Health Coaching Utilizing Lifestyle Action Plans
Culturally sensitive health coaches trained in motivational interviewing provide 10-20 minutes of weekly phone-based health coaching. They not only guide the patient in creating a SMART goal, but assess and build off of the previous weeks' goal and problem-solve with the patient. During the week, the coach and patient text regarding daily blood glucose monitoring with real-time feedback and coaching about the implementation of the patients' goal.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change of HOMA2-IR
Délai: Beginning and End of 12 Weeks
Homeostatic Model Assessment of Insulin Resistance as a surrogate measure of upstream diabetic control
Beginning and End of 12 Weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
sBP
Délai: Beginning and End of 12 Weeks
systolic blood pressure in mm Hg
Beginning and End of 12 Weeks
dBP
Délai: Beginning and End of 12 Weeks
diastolic blood pressure in mm Hg
Beginning and End of 12 Weeks
BMI
Délai: Beginning and End of 12 Weeks
Body Mass Index as an aggregate of weight and height
Beginning and End of 12 Weeks
Hemoglobin A1C
Délai: Beginning and End of 12 Weeks
Measure of downstream diabetic control
Beginning and End of 12 Weeks
Change in Diabetic Medications
Délai: Beginning and End of 12 Weeks
change in number of the diabetic medications at the beginning and end of the 12 weeks
Beginning and End of 12 Weeks
EVS
Délai: Beginning and End of 12 Weeks
Exercise Vital Sign: minutes of exercise per day * days per week
Beginning and End of 12 Weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Beacon Health System

Collaborateurs

Beacon Health Foundation
Coach Me Health

Les enquêteurs

  • Chercheur principal: Kimberly R Azelton, MD, Beacon Health System
  • Chaise d'étude: Karin Underwood, MBA, Coach Me Health

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 décembre 2020

Achèvement primaire (Anticipé)

20 mai 2021

Achèvement de l'étude (Anticipé)

20 mai 2021

Dates d'inscription aux études

Première soumission

14 avril 2021

Première soumission répondant aux critères de contrôle qualité

3 mai 2021

Première publication (Réel)

4 mai 2021

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 mai 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 mai 2021

Dernière vérification

1 mai 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2127

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

IPD sharing would be considered on a case-by-case basis while in communication with Beacon IRB.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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