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

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ClinicalTrials.gov Identifier: NCT01480804
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : March 28, 2014
Sponsor:
Collaborators:
United States Department of Defense
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Medha Munshi, Joslin Diabetes Center

November 16, 2011
November 29, 2011
March 28, 2014
November 2006
December 2012   (Final data collection date for primary outcome measure)
change in hemoglobin A1c [ Time Frame: 6 and 12 months ]
The primary outcome of the study is to measure change in A1c before and after intervention at 6-months and at 12-months
Same as current
Complete list of historical versions of study NCT01480804 on ClinicalTrials.gov Archive Site
Change in clinical, functional and psycho social tests and questionnaires [ Time Frame: 6 and 12 months ]
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.
Same as current
Not Provided
Not Provided
 
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Diabetes
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
  • 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.
    Intervention: Other: Intervention for age specific barriers to self care
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
Same as current
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
69 Years and older   (Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01480804
06-15
No
Not Provided
Not Provided
Medha Munshi, Joslin Diabetes Center
Joslin Diabetes Center
  • United States Department of Defense
  • Beth Israel Deaconess Medical Center
Principal Investigator: Medha N Munshi, MD Joslin Diabetes Center
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP