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Dynamically Tailored Behavioral Interventions in Diabetes

4 april 2022 bijgewerkt door: Columbia University

Dynamically Tailoring Interventions for Problem-Solving in Diabetes Self-Management Using Self-Monitoring Data - a Randomized Controlled Trial (RCT)

In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 diabetes (T2DM) to individuals' behavioral and glycemic profiles discovered using computational learning and self-monitoring data. This study is a two-arm randomized controlled trial with n=280 participants recruited from the participating Federally Qualified Health Centers (FQHCs). The participants will be randomly assigned to the intervention group and the usual care (control) group with 1-1 allocation ratio. Half of the participants (n=140) will be randomly assigned to a usual care (control) group. Both groups will receive standard diabetes education at their respective FQHC site. In addition, the experimental group will receive instructions to use T2.coach for a minimum of 6 months.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

One of the main difficulties in managing diabetes is that each affected individual requires personally tailored combination of diet, exercise, and medication to effectively control their blood sugar. Rather than strictly following a doctor's prescription, individuals need to carefully examine their lifestyle choices and their impact on their health. Independent learning, experimentation and problem solving become of great importance. However, they can be challenging for individuals with diabetes. In this project, the investigators will refine and evaluate a novel intervention for diabetes self-management that uses computational analysis of self-monitoring data to help individuals with type 2 diabetes identify what daily activities, including consumption of meals, physical activity, and sleep, have impact on blood glucose levels, and suggest modifications to these daily activities to improve blood glucose levels.

Growing evidence highlights significant differences in glycemic function and cultural, social, and economical circumstances of individuals with type 2 diabetes (T2DM) that impact their self-management. Precision medicine strives to personalize medical treatment to an individual's genetic makeup, computationally discovered clinical phenotypes and lifestyle. Studies showed the benefits of tailoring not only medical treatment, but also behavioral interventions. Yet, currently, personalization of self-management in T2DM requires each individual to engage in discovery, reflection, and problem-solving-critical but cognitively demanding activities-or to rely on their healthcare providers. Both of these may present considerable barriers to individuals from medically under-served low income communities. Mobile health (mHealth) solutions in T2DM bring promise of reaching wider populations in need of self-management; however, few such solutions provide assistance with personalizing self-management behaviors. Ongoing efforts on personalizing behavioral interventions outside of T2DM focus on tailoring behavior modification techniques to individuals' psycho-social characteristics, such as self-efficacy ), and tailoring delivery of intervention to individuals' context rather than on personalizing self-management strategies.

The ongoing focus of this research is on developing informatics interventions for diabetes self-management, with a specific focus on discovery with self-monitoring data and on problem-solving for improving glycemic control. In the proposed research the investigators introduce T2.coach, an mHealth intervention that uses computational analysis of self-monitoring data to identify behavioral patterns associated with poor glycemic control and formulate personalized behavioral goals for changing problematic behaviors. This study will evaluate T2.coach's efficacy in a two-arm RCT with stratified randomization conducted with Clinical Directors Network (CDN), a well-recognized primary care practice-based research network (PBRN) of Federally Qualified Health Centers (FQHCs), and Agency for Healthcare Research and Quality (AHRQ)-designated Center of Excellence (P30) for Practice-based Research and Learning.

Studietype

Ingrijpend

Inschrijving (Verwacht)

280

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • New York
      • New York, New York, Verenigde Staten, 10032
        • Werving
        • Columbia University Irving Medical Center
        • Contact:
      • New York, New York, Verenigde Staten, 10018
        • Werving
        • Clinical Directors Network
        • Contact:
        • Onderonderzoeker:
          • Andrea Cassells, MPH
        • Hoofdonderzoeker:
          • Jonathan Tobin, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Patient of the health center for ≥ 6 months and a diagnosis of T2DM
  • HbA1c ≥ 8.0,
  • Aged 18 to 65 years
  • Attends diabetes education program at the health center
  • Owns a basic mobile phone
  • Proficient in either English or Spanish

Exclusion Criteria:

  • Pregnant
  • Presence of severe cognitive impairment (recorded in patient chart),
  • Existence of other serious illnesses (e.g. cancer diagnosis with active treatment, advanced stage heart failure, dialysis, multiple sclerosis, advanced retinopathy, recorded in patient chart),
  • Plans for leaving the FQHC in the next 12 months,
  • Participation in the previous trial of diabetes self-management technologies

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: T2.coach
Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center) and are asked to use T2.coach for 6 months.
Gedragsmatig: T2.coach
T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep. All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals. Examples of behavioral goals include the following: "For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice. Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple." The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement.
Geen tussenkomst: Control
Participants receive standard care (diabetes self-management education provided by their Federally Qualified Community Health Center).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HbA1c value
Tijdsspanne: Baseline, 6 months, 12 months
Hemoglobin A1c
Baseline, 6 months, 12 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
DPSI Score
Tijdsspanne: Baseline, 6 months, 12 months
Diabetes Problem-Solving Inventory (DPSI) is a 9-item, open-ended questionnaire. Answers are coded on a Likert 5-point scale (1-very poor strategy; 5-excellent strategy). The final score ranges from 1 (lowest) to 5 (highest) and an overall score ≤3 indicates poor diabetes problem solving, so a higher score indicates a better outcome.
Baseline, 6 months, 12 months
SCA-I Score
Tijdsspanne: Baseline, 6 months, 12 months
Diabetes Self-Care Inventory (SCA-I) is a 15-item 5-point Likert scale (1-never engage; 5-always engage) for measuring different aspects of diabetes self-care. The final score ranges from 1 (lowest) to 5 (highest) with a higher score indicating better self-care (better outcome).
Baseline, 6 months, 12 months
DSES Score
Tijdsspanne: Baseline, 6 months, 12 months
Diabetes Self-Efficacy Scale (DSES) is a 15-item 10-point Likert scale (1-not at all confident; 4-totally confident) that measures the belief that one can self-manage one's own health, adapted to diabetes. The final score ranges from 1 (lowest) to 4 (highest) with a lower score indicating poor self-efficacy (worse outcome).
Baseline, 6 months, 12 months
PAID Score
Tijdsspanne: Baseline, 6 months, 12 months
Problem Areas in Diabetes (PAID) is a 20-item 5-point Likert scale (0-not a problem; 4-very serious problem) that measures the emotional aspect of living with diabetes. The final score ranges from 0 (lowest) to 80 (highest), with a higher score indicating greater emotional discomfort (worse outcome).
Baseline, 6 months, 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Columbia University

Medewerkers

University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Clinical Directors Network

Onderzoekers

  • Hoofdonderzoeker: Olena Mamykina, PhD, Columbia University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 januari 2020

Primaire voltooiing (Verwacht)

30 september 2023

Studie voltooiing (Verwacht)

30 september 2023

Studieregistratiedata

Eerst ingediend

9 januari 2020

Eerst ingediend dat voldeed aan de QC-criteria

9 januari 2020

Eerst geplaatst (Werkelijk)

13 januari 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 april 2022

Laatste update ingediend die voldeed aan QC-criteria

4 april 2022

Laatst geverifieerd

1 april 2022

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AAAS5528
  • R01DK113189 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Nee

Beschrijving IPD-plan

Due to the sensitive nature of individual participant data (IPD) collected in this study, the dataset will only be made available for other potential users under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op T2.coach

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