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NCT Number: NCT01480804

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

69 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Isreal Deaconess Medical Center, Boston, Massachusetts, United States

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About this study

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.

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 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

Treatment and study plan

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.

Other names: Clinical, Functional, Psychosocial, Economic

Primary outcomes

  1. change in hemoglobin A1c

    Time frame: 6 and 12 months

    The primary outcome of the study is to measure change in A1c before and after intervention at 6-months and at 12-months

Secondary outcomes

  1. Change in clinical, functional and psycho social tests and questionnaires

    Time frame: 6 and 12 months

    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.

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • United States Department of Defense

Registry information

Acronym: DISCO

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
Nov 29, 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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