Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study (DISCO)

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01480804
First received: November 16, 2011
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

The purpose of this research study is to identify barriers affecting self care in older patients with diabetes and to provide coping strategies for these barriers with help from a care manager (Geriatric Life Specialist) to improve clinical, economical, functional and psychosocial parameters.


Condition Intervention
Diabetes
Other: Intervention for age specific barriers to self care

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: An Intervention Study

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

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


Secondary Outcome Measures:
  • Change in clinical, functional and psycho social tests and questionnaires [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Tests, surveys and questionnaires used during study visits are as follows: Demographic and medical history, hypoglycemia history and calendar, medication adherence survey, modified clock making test, trail making test A and B, verbal fluency test, activities of daily living, instrumental activities of daily living, 6 minute walk test, Tinetti test, geriatric depression scale, problem areas in diabetes assessment, self care inventory, determine nutrition test, social support assessment.


Enrollment: 48
Study Start Date: November 2006
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 group
The subjects in this group underwent evaluation for barriers to self care by a diabetes educators well versed with age specific barriers. After consideration of patients clinical, functional, and psychosocial background a geriatric diabetes team devised strategy to help patients cope respective barriers. A care manager then implemented the coping strategies by educating patients and caregivers. She also made home visits to assess any safety issues not know to clinic based geriatric team. She helped the patients and caregivers with all aspects of care coordination. Patients in this group received phone contact from care managers as many times as needed over the six month intervention period.
Other: Intervention for age specific barriers to self care
The intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by care manager over 6 month period in person and by phone calls. During the six to twelve month period subjects did not have any contact with study staff or care manager.
Other Names:
  • Clinical
  • Functional
  • Psychosocial
  • Economic
No Intervention: Attention Control Group
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 patents in this group for a total of eleven time within the first six months. The phone calls were forces 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, with addition of a care manager, 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 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. We will also explore whether improved blood glucose control will improve blood circulation in the brain that is compromised in elderly with diabetes.

  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 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, etc)
  • Patients will be excluded from participation in Study Aim 3 if they have a history of orthostatic hypotension, TIA, or vertebral basilar insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480804

Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Beth Israel Deaconess Medical Center
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: NCT01480804     History of Changes
Other Study ID Numbers: 06-15
Study First Received: November 16, 2011
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Barriers
Intervention
Elderly
glycemic control

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

ClinicalTrials.gov processed this record on April 17, 2014