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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Intervention for age specific barriers to self care

• Registration Number: NCT01480804
• Lead Sponsor: Joslin Diabetes Center

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-29
• 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: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Geriatric diabetes team intervention group	Intervention for age specific barriers to self care	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

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

Beth Isreal Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States