Clinical trial NCT01480804: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Official title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Barriers
Intervention
Elderly
glycemic control
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Beth Israel Deaconess Medical Center
First posted: 2011-11-29
Enrollment: 48
Sex: ALL
Minimum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: change in hemoglobin A1c
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Change in clinical, functional and psycho social tests and questionnaires
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Isreal Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
Study officials:
affiliation: Joslin Diabetes Center
name: Medha N Munshi, MD
role: PRINCIPAL_INVESTIGATOR
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