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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: MedLink System

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Northwestern Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to Antidepressant Medication	Frequency of medication usage from baseline to end of treatment	Baseline, Week 4, Week 8, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.	Baseline, Week 4, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 17, 2013
• First Submitted That Met QC Criteria: July 24, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Depression; Adherence; Telemedicine; Primary Care; Antidepressant Medication; Mobile Smartphone Intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: R34MH095907-02-RCTML; R34MH095907-02 (U.S. NIH Grant/Contract)