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临床试验/NCT02429297
NCT02429297已完成不适用

Developing Accessible Telehealth Programs for Diabetes and Hypertension Management in Bolivia

University of Michigan1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2014年6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
110
试验地点
1
主要终点
Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)

研究概览

简要总结

The purpose of the study is to evaluate the feasibility and impact of an automated phone system in monitoring and improving self-care and health outcomes among patients with diabetes and/or hypertension in Bolivia, in addition to assessing the additional benefit of support from a family member or friend.

详细描述

All patients will receive weekly automated calls with feedback to the clinical team. Blood pressures will be taken for all patients by researchers and finger-stick blood glucose readings will be taken at baseline for diabetic patients only and if possible, at follow-up. Fingersticks will use the patient's own glucometer or standard home glucometers donated by the project to the clinic. Patients will be informed about their blood pressure results; and, the clinic will be alerted if the systolic BP exceeds 150.

If participants enroll with a CarePartner, they will be randomized to have their CarePartner receive weekly automated updates focused on symptom monitoring and patient self-care (HITCM+CP) versus usual care (no updates to CarePartner), HITCM-only. All participants will receive a weekly 10-15 minute automated phone call to their cell phone for disease assessment and self-care support for up to 16 weeks. Some patients with hypertension may be provided with in-home cuffs for measurement of blood pressure throughout the study. During enrollment, the research team will explain how the cuffs are used, as well as how to work the automated phone system. During patients' automated calls, they will be asked questions about their self-care relevant to their diagnosis, blood pressure regimen and readings (hypertension only), diet, glucose monitoring and symptoms of high/low blood sugar (diabetes only) and medication adherence. Based on the patient's self-report, they will receive targeted suggestions for how to improve their self-management. No identifying information is included in the automated call sent to the patient's phone other than the patient's first name. At the end of each automated call, patients will hear the phone number of their clinic, which they can call for a health problem or to disenroll from the program. At the time of recruitment, an initial automated call will be sent to the patient's phone so that they can learn what to expect and have the chance to ask questions of the research associate.

In the event that the patient reports a health or self-care problem during their call (i.e., the patient reports rarely or never taking their medication), a report will automatically be generated and sent by email to the research team plus the patient's designated clinician so that follow-up can take place. The secure email address will be verified with each clinician, and be password protected.

The intervention will last up to 16 weeks, after which the patient will have a follow-up meeting with the research team and will complete a survey about the program. All follow-ups will take place either in person or over the phone. Patients will receive an incentive at follow-up at no more than $10 USD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 21-80 years of age
  • Diagnosis of hypertension, a systolic blood pressure > 140mmHg, and/or diagnosis of diabetes
  • Access to a functional cell phone
  • Able to respond to automated telephone calls

排除标准

  • Life-threatening health problem such as cancer with less than a six month life expectancy
  • Are visiting the clinic for an urgent health problem (for themselves)
  • If they have severe mental illness as reported by their clinical team

研究组 & 干预措施

Patient Only - HITCM-only

Experimental

Patients enrolling without a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team.

干预措施: HITCM-only (Other)

Patient & CarePartner - HITCM-only

Experimental

Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team.

干预措施: HITCM-only (Other)

Patient & CarePartner - HITCM+CP

Experimental

Patients enrolling with a CarePartner receive weekly Health Information Technology/Care Manager (HITCM) automated assessment and self-care support calls with feedback to the clinical team plus updates to their CarePartner via phone or email.

干预措施: HITCM+CP (Other)

结局指标

主要结局

Change from baseline on self-care behaviors and health at 16 weeks (questionnaire)

时间窗: Up to 16 weeks

次要结局

  • Evaluate program feasibility (questionnaire, satisfaction, and usage rates)(Up to 16 weeks)
  • Patient satisfaction (satisfaction questionnaire)(Up to 16 weeks)

研究者

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

John Piette

VA Senior Research Career Scientist, Professor of Health Behavior and Health Education and of Internal Medicine

University of Michigan

研究点 (1)

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