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临床试验/NCT01480804
NCT01480804已完成不适用

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

Joslin Diabetes Center2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2006年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
change in hemoglobin A1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
69 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Intervention for age specific barriers to self care (Other)

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.

结局指标

主要结局

change in hemoglobin A1c

时间窗: 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

次要结局

  • Change in clinical, functional and psycho social tests and questionnaires(6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Medha Munshi

Director of Geriactric Diabetes Clinic

Joslin Diabetes Center

研究点 (2)

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