NCT02127216

Brief Summary

In 2010, 25.8 million people in the US, or 8.3% of the population were reported to have diabetes. Type 2 diabetes mellitus (T2DM) is especially prevalent among older adults: 26.9% of people 65 years or older have diabetes with 50% being pre-diabetic. Diabetes is the leading cause of blindness, kidney disease and lower-limb amputation among older adults, and is also a major risk factor for cardiovascular disease. Fortunately, diabetes and its related complications are very amenable to lifestyle changes. Engagement with healthcare providers can significantly affects behavior and disease management of practices of individuals as does social engagement. The use of mobile technology and better engagement with providers and peer support networks may support diabetes self-care management. Individual patient personality attributes may affect the success of technology interventions. In this study, the investigators propose to design and test a motivation psychology-based smart engagement system (MOSES), which is a software application on a digital tablet device. The pre-loaded tablets will be provided to adults with T2DM (age 60+ with high glucose). The software will allow the patients to record diabetes self-care activities (exercise, glucose, nutrition, medication adherence), pursue goals, support communication between the patient and a health coach, support communication between peer patients, and visualize health status more easily by patients and providers. This research program will enroll 88 patients (4 intervention groups of 12 persons each and a 40-person control group) in a 90-day pilot study to test and refine the design of the application and its effectiveness in supporting care plan goals. Primary Aim 1: Design, implement, and optimize a motivation psychology-based smart engagement system (MOSES) for older adults with diabetes. Secondary Aim 2: Determine if providing older adult diabetic patients to care managers and peers via a digital tablet-based software application leads to improved diabetes management as measured by blood glucose control. Secondary Aim 3: Refine the personality attributes used to tailor the interaction with the application.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2020

Enrollment Period

7.9 years

First QC Date

April 29, 2014

Last Update Submit

July 10, 2020

Conditions

Keywords

Mobile HealthDiabetesSelf-Care of Diabetes

Outcome Measures

Primary Outcomes (1)

  • Improvement in hemoglobin A1c

    3 months

Secondary Outcomes (1)

  • Adherence to diabetes care plan

    3 months

Study Arms (5)

Standard of Care Group - A

NO INTERVENTION

The control group

MOSES - Group B

ACTIVE COMPARATOR

Individual patients using application and pedometer without healthcare provider support

Behavioral: MOSES

MOSES - Group C

ACTIVE COMPARATOR

Individual patients using application and pedometer with healthcare provider support

Behavioral: MOSES

MOSES - Group D

ACTIVE COMPARATOR

Peer patient teams using application and pedometer without healthcare provider support

Behavioral: MOSES

MOSES - Group E

ACTIVE COMPARATOR

Peer patient teams using application and pedometer with healthcare provider support

Behavioral: MOSES

Interventions

MOSESBEHAVIORAL

MOSES is an integrated system between a patient, peer patients, and healthcare providers.

Also known as: Motivation Psychology-based Smart Engagement System
MOSES - Group BMOSES - Group CMOSES - Group DMOSES - Group E

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans 60 years of age and older with an HbA1c of \>7.9%
  • Recieving routine medical care within the University of Maryland Medical Center Midtown Campus (UMMCMC) who are 60 years of age and older with HbA1c of \>7.9%

You may not qualify if:

  • Unable to provide informed consent
  • Blindness
  • Deaf
  • Type I DM
  • Active Serious Mental Illness
  • Homelessness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Nanette Steinle, MD

    Baltimore VA Maryland Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2014

First Posted

April 30, 2014

Study Start

June 1, 2014

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

July 14, 2020

Record last verified: 2020-07

Locations