Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study (DISCO)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Identifying and Overcoming Barriers to Diabetes Management in the Elderly: A Cost-effective Intervention Study|
- Hemoglobin A1c [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]The primary outcomes of the study is to measure change in A1c before and after intervention.
- Hypoglycemia [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Frequency of hypoglycemia by history and by hypoglycemia calendar
- functionality [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B
- Depression [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Geriatric depression scale
- Self care inventory - revised [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]frequency of self-care measures
- Problem areas in diabetes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]Measure of diabetes-related distress
- Economic impact [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]number of emergency room visit, hospitalizations for diabetes-related illnesses, out-patient care utilization in the form of clinic visits
|Study Start Date:||July 2007|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Geriatric Diabetes Team Intervention
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.
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.
No Intervention: Atention Control Arm
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486290
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Medha N Munshi, MD||Joslin Diabetes Center|