Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
David Mohr, Northwestern University
ClinicalTrials.gov Identifier:
NCT01909973
First received: July 17, 2013
Last updated: January 12, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Depression
Behavioral: MedLink System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Adherence to Antidepressant Medication [ Time Frame: Baseline to up to 12 weeks ] [ Designated as safety issue: No ]
    Frequency of medication usage from baseline to end of treatment


Secondary Outcome Measures:
  • Changes in depression [ Time Frame: Baseline to up to 12 weeks ] [ Designated as safety issue: No ]
    Severity of depressive symptoms from baseline to end of treatment


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MedLink System
For 12 weeks, the patient who is newly prescribed antidepressant medication will receive a mobile phone and a GSM enable pill bottle in order to provide and receive feedback regarding medication adherence.
Behavioral: MedLink System

Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.

The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status.

No Intervention: Treatment As Usual
Patients will continue to receive treatment as usual from their primary care doctor. Patients in this arm will also receive a free mobile phone for the 12 weeks of the intervention.

Detailed Description:

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 via short message service (or text), 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 study is to develop and pilot the medLink system. Development will employ an iterative user-centered approach. The pilot trial will compare 12 weeks of the medLink system to a treatment as usual control among primary care patients with MDD initiating ADM treatment. Outcomes will include patient adherence to ADM, physician adherence to treatment guidelines, and depression.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909973

Contacts
Contact: Susan M Kaiser, MPH 312-503-1249
Contact: John Patena, MPH 312-503-3741

Locations
United States, Illinois
Northwestern University, Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: David C Mohr, Ph.D. Northwestern University
  More Information

No publications provided

Responsible Party: David Mohr, Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01909973     History of Changes
Obsolete Identifiers: NCT01583764
Other Study ID Numbers: R34MH095907-02
Study First Received: July 17, 2013
Last Updated: January 12, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Northwestern University:
Depression
Antidepressant Medication
Adherence
Mobile Smartphone Intervention
Telemedicine
Primary Care

ClinicalTrials.gov processed this record on March 03, 2015