NCT04600622

Brief Summary

The proposed project will use community based participatory research to adapt an existing diabetes self-management and education intervention with a telehealth intervention to be culturally relevant for rural English- and Spanish-speaking populations. Participants and care partners will receive a one-time, 5.5-hour telehealth intervention from a multidisciplinary team specializing in diabetes. The overarching aim of this study is to provide a sustainable model to provide diabetes specialty care to rural populations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

October 15, 2020

Last Update Submit

August 29, 2023

Conditions

Diabetes Mellitus

Keywords

diabetestelehealthruralSpanishEnglishcommunity based participatory research

Outcome Measures

Primary Outcomes (2)

  • Average Acceptability Score

    Average acceptability score on the intervention acceptability measure

    3 months

  • Average Feasibility Score

    Average feasibility score on the feasibility measure

    3 months

Secondary Outcomes (3)

  • Change in glycosylated hemoglobin A1C

    Baseline to 3 months

  • Change in diabetes distress score

    Baseline to 3 months

  • Change in Family and Friend Involvement in Diabetes score

    Baseline to 3 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will receive Rural Diabetes One-Day Education and Care program (R-D1D). A one time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.

Behavioral: Rural Diabetes One-Day Education and Care program (R-D1D)

Active Comparator

ACTIVE COMPARATOR

Participants will receive diabetes education materials.

Behavioral: Diabetes Education Materials

Interventions

Rural Diabetes One-Day Education and Care program (R-D1D)BEHAVIORAL

One time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.

Intervention Arm
Diabetes Education MaterialsBEHAVIORAL

Diabetes Education Materials

Active Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a known diagnosis of type 1 or 2 diabetes with any A1C level
  • years old or older
  • Live in a rural eastern Colorado
  • Speak and understand English or Spanish
  • Willing to participate in a telehealth intervention at the clinic where they usually receive care or in their own home if an in-person meeting is prohibited due to the pandemic

You may not qualify if:

  • Are participating in another diabetes study
  • Significant cognitive impairment
  • Pregnant or planning to become pregnant as diabetes management recommendations are different in pregnancy
  • Life expectancy of \<6 months
  • Plan to move during the time of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80204, United States

Location

Related Publications (1)

  • Litchman ML, Kwan BM, Zittleman L, Simonetti J, Iacob E, Curcija K, Neuberger J, Latendress G, Oser TK. A Telehealth Diabetes Intervention for Rural Populations: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 14;11(6):e34255. doi: 10.2196/34255.

    PMID: 35700026DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Michelle L Litchman, PhD

    University of Utah College of Nursing

    PRINCIPAL INVESTIGATOR

  • Tamara K Oser, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Profesor

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 23, 2020

Study Start

June 17, 2021

Primary Completion

April 8, 2022

Study Completion

August 24, 2022

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)