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Motivation Psychology-based Smart Engagement System (MOSES)

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ClinicalTrials.gov Identifier: NCT02127216
Recruitment Status : Active, not recruiting
First Posted : April 30, 2014
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
Baltimore Research & Education Foundation, Inc.

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: MOSES Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Motivation Psychology-based Smart Engagement System for Improved Older Adult Chronic Disease Management
Study Start Date : June 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Improvement in hemoglobin A1c [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Adherence to diabetes care plan [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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%

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02127216


Locations
United States, Maryland
Baltimore VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Baltimore Research & Education Foundation, Inc.
University of Maryland
Investigators
Principal Investigator: Nanette Steinle, MD Baltimore VA Maryland Health Care System

Responsible Party: Baltimore Research & Education Foundation, Inc.
ClinicalTrials.gov Identifier: NCT02127216     History of Changes
Other Study ID Numbers: CHIDS-MOSES
First Posted: April 30, 2014    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017

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