Diabetes
Conditions
Keywords
Barriers, Intervention, Elderly, glycemic control
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.
Interventions
OTHERIntervention 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.
Sponsors
United States Department of Defense
Beth Israel Deaconess Medical Center
Joslin Diabetes Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
69 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in hemoglobin A1c | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical, functional and psycho social tests and questionnaires | 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. |
Countries
United States
Outcome results
None listed