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

Diabetes Clinical Trial

— DISCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480804
• Other study ID #: 06-15
• Status: Completed
• Phase: N/A
• First received: November 16, 2011
• Last updated: March 26, 2014
• Start date: November 2006
• Est. completion date: December 2012

Study information

• Verified date: March 2014
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 69 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Intervention 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.

Locations

Country	Name	City	State
United States	Beth Isreal Deaconess Medical Center	Boston	Massachusetts
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Beth Israel Deaconess Medical Center, United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No