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

Diabetes Clinical Trial

— DISCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01486290
• Other study ID #: 07-03
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: March 26, 2014
• Start date: July 2007
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• 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 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

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

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• Behavioral
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.

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	American Diabetes Association

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c	The primary outcomes of the study is to measure change in A1c before and after intervention.	6 and 12 months	No
Secondary	Hypoglycemia	Frequency of hypoglycemia by history and by hypoglycemia calendar	6 and 12 months	No
Secondary	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	No
Secondary	Cognitive function	cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B	6 and 12 months	No
Secondary	Depression	Geriatric depression scale	6 and 12 months	No
Secondary	Self care inventory - revised	frequency of self-care measures	6 and 12 months	No
Secondary	Problem areas in diabetes	Measure of diabetes-related distress	6 and 12 months	No
Secondary	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	No