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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Mohr, Northwestern University
ClinicalTrials.gov Identifier:
NCT01583764
First received: April 20, 2012
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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. The most effective strategies address both provider and patient behaviors, usually through the use of a case-manager who monitors and supports patient adherence and response to treatment, and provides actionable feedback to the PCP. However, case-managers have not been widely implemented in primary care settings.

Recent technology developments have opened new opportunities to improve health care, and to link patients and their providers. The investigators proposal harnesses these advances to develop and pilot the medLink system. ADM adherence will be passively measured using an electronic pill dispenser, which is connected to a mobile smartphone via 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 proposal 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.


Condition Intervention Phase
Depressive Disorder, Major
Behavioral: Medlink system
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mobile Technology to Engage and Link Patients and Providers in Antidepressant Treatment

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Objective patient adherence to antidepressant medication [ Time Frame: 4,8 and 12 weeks ] [ Designated as safety issue: No ]
    Objective adherence will be evaluated using the pill dispenser, which contains a chip that can monitor with a time and date stamp each dispensing of a dose. The adherence metric will be % of days adherent. This method is potentially the most objective, but is vulnerable to technical problems.

  • Patient Adherence Questionnaire (PAQ) [ Time Frame: 4,8 and 12 weeks ] [ Designated as safety issue: No ]
    Self-reported adherence will be measured using the Patient Adherence Questionnaire (PAQ) at weeks 4, 8 and 12. The PAQ, developed for the STAR*D trial. Patients will be asked to report on the previous 2 weeks' adherence. Self-reported data has generally been found to underestimate actual medication use, and is subject to recall bias and social desirability, but is less vulnerable to threats to technical reliability.

  • Adequency of anti depressant medication dosage [ Time Frame: 4, 9 and 13 weeks. ] [ Designated as safety issue: No ]
    Adequacy of dosage will use a framework developed by Simon in which doses are coded 0=subthreshold; 1=minimal clinical dosage; 2=twice minimal and 3=three times minimal or greater. Based on the prescription data obtained from the EMR, a score for each week will be generated.

  • Number of contacts with Primary Care team [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Guideline-congruent care will be operationalized as the number of patient visits or telephone consultations, and the number of medication and dose changes, consistent with other trials of interventions with primary care physicians.


Secondary Outcome Measures:
  • Depression [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: No ]
    Depression will be measured by the QIDS-C, IDS-SR, and MINI MDD module

  • Usability and Satisfaction with system [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    This will be measured through use of the Medlink system and the USE questionnaires

  • Medication side effects [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Side Effects will be measured by the Patient Report Inventory of Side Effects (PRISE)

  • Attitudes towards Anti Depressant Medication [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Attitudes towards ADMs will be measured using the Beliefs about Medicine scale and the Depression Beliefs Inventory


Estimated Enrollment: 50
Study Start Date: June 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: January 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has been prescribed an anti depressant medicaition by an Northwestern University PCP, but has not yet initiated treatment
  • Has a DSM-IV diagnosis of non-psychotic MDD as assessed using the Mini International Neuropsychiatric Interview (MINI)plus a score of 12 or greater on the Quick Inventory of Depressive Symptomatology - Clinician Rated (QIDS-C).
  • 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 currently taking an anti depressant 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, or other diagnosis for which participation in this trial is either inappropriate or dangerous
  • Hazardous substance or alcohol use for which another treatment would be indicated
  • 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: NCT01583764

Contacts
Contact: Susan M Kaiser, MPH 312-503-1249 susan.kaiser@northwestern.edu
Contact: Joyce Ho, Ph.D. 312-503-5387 j-ho@northwestern.edu

Locations
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: David C Mohr, Ph.D.         
Sponsors and Collaborators
Northwestern University
  More Information

No publications provided

Responsible Party: David Mohr, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01583764     History of Changes
Other Study ID Numbers: R34 MH095907-01, R34MH095907-01
Study First Received: April 20, 2012
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Northwestern University:
Depressive Disorder, Major
Antidepressant Medication
Telemedicine
Primary Care
Internet

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Antidepressive Agents
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014