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

NCT01480804 | Completed

• 1 other identifier: 06-15
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

Barriers; Intervention; Elderly; glycemic control

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in clinical, functional and psycho social tests and questionnaires

  6 and 12 months

Study Arms (2)

Geriatric diabetes team intervention group

EXPERIMENTAL

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.

Other: Intervention for age specific barriers to self care

Attention Control Group

NO INTERVENTION

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 patents in this group for a total of eleven time within the first six months. The phone calls were forces toward general discussion without any diabetes related advice.

Interventions

Intervention for age specific barriers to self care OTHER

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.

Also known as: Clinical, Functional, Psychosocial, Economic

Geriatric diabetes team intervention group

Eligibility Criteria

• Age: 69 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• United States Department of Defense: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Isreal Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Methods; Functional Status; Economics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Health Care Economics and Organizations

Study Officials

• Medha N Munshi, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Geriactric Diabetes Clinic

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 28, 2014

Record last verified: 2014-03

Locations

US (2)