Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment

NCT01909973 | Completed Results DMC

• 2 other identifiers: R34MH095907-02-RCTMLR34MH095907-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression

Keywords

Depression; Antidepressant Medication; Adherence; Mobile Smartphone Intervention; Telemedicine; Primary Care

Outcome Measures

Primary Outcomes (1)

• Adherence to Antidepressant Medication

  Frequency of medication usage from baseline to end of treatment

  Baseline, Week 4, Week 8, Week 12

Secondary Outcomes (1)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, Week 4, Week 8, Week 12

Study Arms (2)

MedLink System

EXPERIMENTAL

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

Treatment As Usual

NO INTERVENTION

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.

Interventions

MedLink System BEHAVIORAL

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.

MedLink System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University, Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: David C. Mohr, PhD
• Organization: Northwestern University

d-mohr@northwestern.edu

312-503-1403

Study Officials

• David C Mohr, Ph.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Behavioral Intervention Technologies; Professor, Department of Preventive Medicine

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: July 29, 2013
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 8, 2019
• Results First Posted: October 8, 2019

Record last verified: 2019-10

Locations

US (1)