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临床试验/NCT02583230
NCT02583230已完成不适用

Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment (MedLink)

Northwestern University0 个研究点目标入组 11 人开始时间: 2014年4月最近更新:
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
11
主要终点
Adherence to Antidepressant Medication

研究概览

简要总结

The goal of this project is to develop and pilot a mobile smartphone delivered intervention that will improve antidepressant medication care by providing medication adherence monitoring and support to the patient, feedback on patient adherence and response to treatment to the primary care team, and information to both patients and providers on guideline-congruent care personalized to the patient's response to antidepressant medication.

详细描述

Major depressive disorder (MDD) is common and imposes a very high societal burden in terms of cost, morbidity, suffering, and mortality. While primary care is the de facto site for treatment of MDD, outcomes in primary care are poor. Two principal reasons for the poor outcomes in primary care are poor patient adherence to antidepressant medications (ADMs) and the failure of physicians to provide guideline-congruent care. This problem is aggravated by a lack of communication between patients and the care team.

A growing body of research indicates that primary care-centered strategies aimed at enhancing guideline-congruent care have not been effective. Interventions aimed at improving adherence in the patient have been successful in changing patient adherence behavior; however these frequently fail to improve depression outcomes, particularly when there is no intervention on the physician side to encourage optimization of ADMs. Recent developments in information and communications technologies (ICT) have opened new opportunities to improve health and mental health care, and to link patients and their providers. This study harnesses these advances to develop and pilot a system where ADM adherence will be passively measured using an electronic pill dispenser. The dispenser is connected to a mobile smartphone via Global System for Mobile Communications (GSM), so that targeted, timely reminders can be provided when the patient fails to take the ADM. When the patient is adherent, the patient will not be bothered with reminders. Depressive symptoms and side-effects will be periodically monitored weekly via the phone. Every 4 weeks, or if indicated (e.g intolerable side effects or urgent situations), primary care teams will receive notifications via the electronic medical record that include a summary of patient data on treatment response and side effects, guideline-congruent treatment recommendations based on patient data and a recommendation to contact the patient, if indicated. Simultaneously, a similar message will be provided to the patient, including feedback, possible treatment options, and a recommendation to contact the physician's office. Thus, both the patient and care team will be activated to provide, request and adhere to guideline-congruent care.

The aim of this 8 week field trial is to develop and pilot the MedLink system. Development will employ an iterative user-centered approach. Primary outcome will be patient adherence; secondary outcomes will be depression, system use, and usability and satisfaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Has been prescribed an antidepressant medication by a Primary Care Provider, but has not yet initiated treatment
  • Has depression determined by primary care physician
  • Is familiar with the use of mobile phones
  • Is able and willing to carry the mobile phone
  • Is able to speak and read English
  • Is at least 18 years of age

排除标准

  • Is current taking an antidepressant medication or has taken one in the previous 3 months
  • Has visual, hearing, voice, or motor impairment that would prevent completion of study procedures or use of mobile phone
  • Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current substance dependence, or other diagnosis for which participation in this trial is either inappropriate or dangerous. Patients with substance dependence diagnoses who have been clean and sober for 12 months will be admitted if otherwise eligible
  • Is severely suicidal (has ideation, plan, and intent)

研究组 & 干预措施

MedLink

Experimental

For 8 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone app (and a phone if they do not have a compatible Android phone) and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.

干预措施: MedLink System (Behavioral)

结局指标

主要结局

Adherence to Antidepressant Medication

时间窗: 8 weeks

Number of days medication was taken when a dose was expected. Measured through % of days adherent on Wisepill pillbox as well as 2. Self-reported adherence: Patient Adherence Questionnaire (PAQ).

次要结局

  • Patient Health Questionnaire-9 (PHQ-9)(Baseline, Week 4, and Week 8)
  • Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C)(Baseline, Week 4, and Week 8)

研究者

申办方类型
Other
责任方
Sponsor

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