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Completed

NCT Number: NCT01486290

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

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.

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Key information

Age range

69 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Clinical, Education, Nutrition, Care coordination

Primary outcomes

  1. Hemoglobin A1c

    Time frame: 6 and 12 months

    The primary outcomes of the study is to measure change in A1c before and after intervention.

Secondary outcomes

  1. Hypoglycemia

    Time frame: 6 and 12 months

    Frequency of hypoglycemia by history and by hypoglycemia calendar

  2. functionality

    Time frame: 6 and 12 months

    6-minute walk test, Tinetti test, number of falls and fear of falls, activities of daily living and instrumental activities of daily living

  3. Cognitive function

    Time frame: 6 and 12 months

    cognitive function test by modified clock drawing test, verbal fluency and Trail-making tests A and B

  4. Depression

    Time frame: 6 and 12 months

    Geriatric depression scale

  5. Self care inventory - revised

    Time frame: 6 and 12 months

    frequency of self-care measures

  6. Problem areas in diabetes

    Time frame: 6 and 12 months

    Measure of diabetes-related distress

  7. Economic impact

    Time frame: 6 and 12 months

    number of emergency room visit, hospitalizations for diabetes-related illnesses, out-patient care utilization in the form of clinic visits

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • American Diabetes Association

Registry information

Acronym: DISCO

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Dec 6, 2011
Registry last updated
Mar 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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