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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Behavioral

• Registration Number: NCT01486290
• Lead Sponsor: Joslin Diabetes Center

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric Diabetes Team Intervention	Behavioral	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.

Primary Outcome Measures

Name	Time	Method
Hemoglobin A1c	6 and 12 months	The primary outcomes of the study is to measure change in A1c before and after intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States