Clinical trial NCT03960424: Diabetes Management Program for Hispanic/Latino
Official title: Diabetes Management Program for Hispanic/Latino
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Type 2 Diabetes
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2019-05-23
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Mixed Methods Design, incorporating adaptations before RCT trial commencement.
Primary purpose: TREATMENT

Brief summary: To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.

Detailed description: The investigators propose a multiphase mixed method, Comparative Effectiveness Research Randomized Control Trial (CER RCT) to:

Specific Aim 1: Assess usability of an evidence-based DTM intervention utilizing a Community Based Participatory Research (CBPR) approach and adapt it to facilitate acceptability and feasibility in a population of H/L patients with T2D, and their caregivers and providers.

Specific Aim 2: Assess whether H/L patients receiving DTM attain significantly improved patient-centered outcomes compared to COM, through a CER RCT. Expected outcomes include improved diabetes quality of life (QoL), glucose management (GM), blood pressure (BP), cholesterol, medication adherence, and diabetes self-efficacy (SE), and reduced diabetes distress, problem areas in diabetes (PAID), inpatient utilization, unscheduled T2D physician visits and sick days.

Eligibility criteria: Inclusion Criteria:

* Hispanic patients with a diagnosis of diabetes
* Speaks English or Spanish

Exclusion Criteria:

* Patient is not Hispanic
* Patient does not have a diagnosis of diabetes

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: 12 months
measure: Hypoglycemia episodes
timeFrame: 6 months
measure: Adherence
timeFrame: 6 months
measure: Diabetes self-efficacy
timeFrame: 6 months
measure: PAID
timeFrame: 6 months
measure: Weight
timeFrame: 6 months
measure: Cholesterol
timeFrame: 6 months
measure: Blood Pressure
timeFrame: 6 months
measure: Diabetes Quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Feinstein Institute of Medical Research
state: New York
Study officials:
affiliation: Feinstein Institute for Medical Research
name: Renee Pekmezaris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pekmezaris R, Williams MS, Pascarelli B, Finuf KD, Harris YT, Myers AK, Taylor T, Kline M, Patel VH, Murray LM, McFarlane SI, Pappas K, Lesser ML, Makaryus AN, Martinez S, Kozikowski A, Polo J, Guzman J, Zeltser R, Marino J, Pena M, DiClemente RJ, Granville D. Adapting a home telemonitoring intervention for underserved Hispanic/Latino patients with type 2 diabetes: an acceptability and feasibility study. BMC Med Inform Decis Mak. 2020 Dec 7;20(1):324. doi: 10.1186/s12911-020-01346-0.