Clinical trial NCT01486290: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
Official title: Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Intervention
Cost Effective
Elderly
Glycemic Control
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2011-12-06
Enrollment: 52
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 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.

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 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

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Hypoglycemia
timeFrame: 6 and 12 months
measure: functionality
timeFrame: 6 and 12 months
measure: Cognitive function
timeFrame: 6 and 12 months
measure: Depression
timeFrame: 6 and 12 months
measure: Self care inventory - revised
timeFrame: 6 and 12 months
measure: Problem areas in diabetes
timeFrame: 6 and 12 months
measure: Economic impact
timeFrame: 6 and 12 months
Other outcomes:
Locations:
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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