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

NCT02583230 | Completed Results

• 2 other identifiers: R34MH095907-FTMLR34MH095907
• Study Type: interventional
• Target: 11
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• Adherence to Antidepressant Medication

  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).

  8 weeks

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Behavioral: MedLink System

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

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

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, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 22, 2015
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: October 29, 2018
• Results First Posted: October 29, 2018

Record last verified: 2018-02