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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01486290
Recruitment Status : Completed
First Posted : December 6, 2011
Last Update Posted : March 28, 2014
American Diabetes Association
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center

Brief Summary:
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.

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

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  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
Study Start Date : July 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

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:
  • Clinical
  • Education
  • Nutrition
  • 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.

Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 6 and 12 months ]
    The primary outcomes of the study is to measure change in A1c before and after intervention.

Secondary Outcome Measures :
  1. Hypoglycemia [ Time Frame: 6 and 12 months ]
    Frequency of hypoglycemia by history and by hypoglycemia calendar

  2. 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

  3. 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

  4. Depression [ Time Frame: 6 and 12 months ]
    Geriatric depression scale

  5. Self care inventory - revised [ Time Frame: 6 and 12 months ]
    frequency of self-care measures

  6. Problem areas in diabetes [ Time Frame: 6 and 12 months ]
    Measure of diabetes-related distress

  7. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   69 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01486290

United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
American Diabetes Association
Principal Investigator: Medha N Munshi, MD Joslin Diabetes Center

Benarroch EE, S.P., Low PA, The Valsalva Manuever. In Clinical Autonomic Disroders: Evaluation and Management, L.P. editor, Editor. 1993, Little Brown and company: Boston. p. 209-215.
Low, P.A., Laboratory Evaluation of Autonomic Function. In Clinical Autonomic Disorders, P.A. Low, Editor. 1997, LIppincott-Raven: Philadelphia. p. 179-208.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Medha Munshi, Director of Geriactric Diabetes Clinic, Joslin Diabetes Center Identifier: NCT01486290     History of Changes
Other Study ID Numbers: 07-03
First Posted: December 6, 2011    Key Record Dates
Last Update Posted: March 28, 2014
Last Verified: March 2014

Keywords provided by Medha Munshi, Joslin Diabetes Center:
Cost Effective
Glycemic Control

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