Motivation Psychology-based Smart Engagement System (MOSES)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Baltimore Research & Education Foundation, Inc.
Sponsor:
Information provided by (Responsible Party):
Baltimore Research & Education Foundation, Inc.
ClinicalTrials.gov Identifier:
NCT02127216
First received: April 29, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes
Behavioral: MOSES

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Motivation Psychology-based Smart Engagement System for Improved Older Adult Chronic Disease Management

Resource links provided by NLM:


Further study details as provided by Baltimore Research & Education Foundation, Inc.:

Primary Outcome Measures:
  • Improvement in hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence to diabetes care plan [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: June 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care Group - A
The control group
Active Comparator: MOSES - Group B
Individual patients using application and pedometer without healthcare provider support
Behavioral: MOSES
MOSES is an integrated system between a patient, peer patients, and healthcare providers.
Other Name: Motivation Psychology-based Smart Engagement System
Active Comparator: MOSES - Group C
Individual patients using application and pedometer with healthcare provider support
Behavioral: MOSES
MOSES is an integrated system between a patient, peer patients, and healthcare providers.
Other Name: Motivation Psychology-based Smart Engagement System
Active Comparator: MOSES - Group D
Peer patient teams using application and pedometer without healthcare provider support
Behavioral: MOSES
MOSES is an integrated system between a patient, peer patients, and healthcare providers.
Other Name: Motivation Psychology-based Smart Engagement System
Active Comparator: MOSES - Group E
Peer patient teams using application and pedometer with healthcare provider support
Behavioral: MOSES
MOSES is an integrated system between a patient, peer patients, and healthcare providers.
Other Name: Motivation Psychology-based Smart Engagement System

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Veterans 60 years of age and older with an HbA1c of >7.9%

Exclusion Criteria:

  • Unable to provide informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02127216

Contacts
Contact: Nanette Steinle, MD 410-605-7432 Nanette.Steinle@va.gov

Locations
United States, Maryland
Baltimore VA Maryland Health Care System Not yet recruiting
Baltimore, Maryland, United States, 21201
Contact: Nanette Steinle, MD    410-605-7432    Nanette.Steinle@va.gov   
Contact: Tammy Bremer    410-605-7188    Tammy.Bremer@va.gov   
Principal Investigator: Nanette Steinle, MD         
Sponsors and Collaborators
Baltimore Research & Education Foundation, Inc.
Investigators
Principal Investigator: Nanette Steinle, MD Baltimore VA Maryland Health Care System
  More Information

No publications provided

Responsible Party: Baltimore Research & Education Foundation, Inc.
ClinicalTrials.gov Identifier: NCT02127216     History of Changes
Other Study ID Numbers: CHIDS-MOSES
Study First Received: April 29, 2014
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government
United States: Data and Safety Monitoring Board

Keywords provided by Baltimore Research & Education Foundation, Inc.:
Mobile Health
Diabetes
Self-Care of Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014