Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Behavioral


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 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

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<br>The subjects in this group underwent evaluation for barriers to self care by a diabetes educator well versed with age specific barriers. After consideration of patient clinical, function, and psychosocial background, a geriatric diabetes team devised strategy to help patients cope with respective barriers. An office based diabetes diabetes educator conveyed the strategy to patient and caregivers viz phone calls. the educator called study participants up wot eleven times over a sex month period. | Behavioral: Behavioral<br>* the intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by an office based educator over a six month by phone calls. From six months to twelve months subjects did not have any contact with study staff.<br>* Other names: Care coordination;|
| No Intervention: Atention Control Arm<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 patients in this group for a total of eleven times within the first six months. The Phone calls were focused 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 |
| --- | --- | --- |
| Hemoglobin A1c | The primary outcomes of the study is to measure change in A1c before and after intervention. | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia | Frequency of hypoglycemia by history and by hypoglycemia calendar | 6 and 12 months | 
| functionality | 6-minute walk test, Tinetti test, number of falls and fear of falls, activities of daily living and instrumental activities of daily living | 6 and 12 months | 
| Cognitive function | cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B | 6 and 12 months | 
| Depression | Geriatric depression scale | 6 and 12 months | 
| Self care inventory - revised | frequency of self-care measures | 6 and 12 months | 
| Problem areas in diabetes | Measure of diabetes-related distress | 6 and 12 months | 
| Economic impact | number of emergency room visit, hospitalizations for diabetes-related illnesses, out-patient care utilization in the form of clinic visits | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Cost Effective, Elderly, Glycemic Control