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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identifying and Overcoming Barriers to Diabetes Management in the Elderly: An Intervention Study

Conditions
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Diabetes

Intervention / Treatment
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* Other: Intervention for age specific barriers to self care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Geriatric diabetes team intervention group<br>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<br>* 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.<br>* Other names: Economic;|
| No Intervention: Attention Control Group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in hemoglobin A1c | The primary outcome of the study is to measure change in A1c before and after intervention at 6-months and at 12-months | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical, functional and psycho social tests and questionnaires | 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. | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Barriers, Intervention, Elderly, glycemic control