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

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01486290
First received: November 23, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Diabetes
Behavioral: Behavioral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Hemoglobin A1c [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The primary outcomes of the study is to measure change in A1c before and after intervention.


Secondary Outcome Measures:
  • Hypoglycemia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Frequency of hypoglycemia by history and by hypoglycemia calendar

  • functionality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    6-minute walk test, Tinetti test, number of falls and fear of falls, activities of daily living and instrumental activities of daily living

  • Cognitive function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B

  • Depression [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Geriatric depression scale

  • Self care inventory - revised [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    frequency of self-care measures

  • Problem areas in diabetes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Measure of diabetes-related distress

  • Economic impact [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    number of emergency room visit, hospitalizations for diabetes-related illnesses, out-patient care utilization in the form of clinic visits


Enrollment: 52
Study Start Date: July 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   69 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01486290

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medha Munshi, Director of Geriactric Diabetes Clinic, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01486290     History of Changes
Other Study ID Numbers: 07-03
Study First Received: November 23, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Intervention
Cost Effective
Elderly
Glycemic Control

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

ClinicalTrials.gov processed this record on November 20, 2014