Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study (DISCO)

March 26, 2014 updated by: Medha Munshi, Joslin Diabetes Center
The purpose of this study is to find ways to identify barriers that affect self care in older adult with diabetes and to provide cost effective coping strategies to improve clinical, functional and psychosocial measures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a study to evaluate whether short term focused intervention by a geriatric diabetes team to help overcome barriers to diabetes care in older adults will result in improved clinical, functional, and quality of life measures compared to usual care in a cost effective manner. In addition, we will assess whether the support network formed during intervention by the geriatric diabetes team will empower patients, resulting in long lasting improvement in parameters after intervention is completed.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

69 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 70 years and older
  • Diagnosis of type 1 or type 2 diabetes
  • Seen at Joslin Clinic or Beth Israel Deaconess Medical Center for at least one year
  • HbA1c 8% X 2 in past 6 months without fluctuation of more than 0.5% (i.e. stable poor control)
  • No major change in medications in past 3 months, e.g. addition of insulin or another hypoglycemic agent

Exclusion Criteria:

  • Patients with terminal diseases, e.g. malignancy with expected life expectancy of 12 months or less
  • Patients who live more than 25 miles from Joslin Clinic/Beth Israel Deaconess Medical Center
  • Patients who live in an institutional setting (e.g. nursing home, group home, etc)
  • Patients who are not able to complete outcome assessments, (e.g. poor vision, diminished mental capacity/severe cognitive decline, unable to speak/read/write English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Geriatric Diabetes Team Intervention
The subjects in this group underwent evaluation for barriers to self care by a diabetes educator well versed with age specific barriers. After consideration of patient clinical, function, and psychosocial background, a geriatric diabetes team devised strategy to help patients cope with respective barriers. An office based diabetes diabetes educator conveyed the strategy to patient and caregivers viz phone calls. the educator called study participants up wot eleven times over a sex month period.
Behavioral: Behavioral
the intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by an office based educator over a six month by phone calls. From six months to twelve months subjects did not have any contact with study staff.
Other Names:
  • Education
  • Nutrition
  • Clinical
  • Care coordination
No Intervention: Atention Control Arm
The subjects in the group received similar, in person contact, as the intervention group. an educator, separate from the one involved in the intervention team, called patients in this group for a total of eleven times within the first six months. The Phone calls were focused toward general discussion without any diabetes related advice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 6 and 12 months
The primary outcomes of the study is to measure change in A1c before and after intervention.
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia
Time Frame: 6 and 12 months
Frequency of hypoglycemia by history and by hypoglycemia calendar
6 and 12 months
functionality
Time Frame: 6 and 12 months
6-minute walk test, Tinetti test, number of falls and fear of falls, activities of daily living and instrumental activities of daily living
6 and 12 months
Cognitive function
Time Frame: 6 and 12 months
cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B
6 and 12 months
Depression
Time Frame: 6 and 12 months
Geriatric depression scale
6 and 12 months
Self care inventory - revised
Time Frame: 6 and 12 months
frequency of self-care measures
6 and 12 months
Problem areas in diabetes
Time Frame: 6 and 12 months
Measure of diabetes-related distress
6 and 12 months
Economic impact
Time Frame: 6 and 12 months
number of emergency room visit, hospitalizations for diabetes-related illnesses, out-patient care utilization in the form of clinic visits
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Medha N Munshi, MD, Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

December 2, 2011

First Posted (Estimate)

December 6, 2011

Study Record Updates

Last Update Posted (Estimate)

March 28, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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