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Pilot Study of Annie Text Messaging for Depression Treatment Adherence

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ClinicalTrials.gov Identifier: NCT03930849
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Patients and providers need effective tools to help promote adherence to newly prescribed medications for depression and to determine if this medication is improving depressed mood. This study will test an intervention that uses 1) VA's text messaging program called Annie to help patient's engage in self-management when starting a new medication for depression and 2) My HealtheVet, VA's patient portal, for education and communication with their VA health care team. The goals of this intervention are to improve adherence to depression medication and depressive symptoms in Veterans.

Condition or disease Intervention/treatment Phase
Depression Behavioral: AIMS Behavioral: AIMS plus Not Applicable

Detailed Description:

Background: There are several known challenges to starting a medication for depression, such as side effects and needing four to six weeks before the effects of the medication may be noticed. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve antidepressant adherence and depression outcomes in Veterans initiating medication to treat depression by using Annie, VA's short messaging services (SMS) application and My HealtheVet, VA's patient portal.

Method: Veterans will be eligible if they are initiating a new antidepressant medication as part of their care at the Iowa City VA primary care or mental health. Veterans will be randomized to one of three groups, usual care or 1 of 2 interventional groups (Annie or Annie plus). Veterans in the intervention groups will 1) receive education about depression and the importance of taking medications as prescribed and 2) receive text messages from "Annie" with information and questions for response. For example, are Veterans taking their medication, is their medication working, and how would they rate their mood. They will also receive weekly reports about their responses to Annie through My HealtheVet, VA's patient portal. In addition, Veterans assigned to Annie Plus will receive a weekly phone call to review progress and to answer any questions. Prior to a participant's scheduled follow-up appointment, a summary of information collected to date via Annie will be made available to the clinical team in the medical record. At the end of the study, participants will be invited to complete a recorded interview about their experiences using the Annie text messaging program and to provide any recommendations for changes. VA providers will also be invited to complete a recorded phone interview about their experience with patients using Annie.

For Veterans randomized to the control condition, research staff will provide education about depression and the importance of taking medications as prescribed. Staff will contact participants in this arm by phone just prior to scheduled follow up visits to discuss any concerns the patient may be experiencing. A sample of Veterans will be asked to complete a recorded interview about their medication management at the end of the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will test an intervention designed to improve antidepressant adherence and depression outcomes in Veterans initiating or changing antidepressant medication to treat depression. Veterans will be assigned to 1) use Annie, VA's short message service (SMS) in combination with My HealtheVet, VA's online patient portal, 2) use Annie plus receive a weekly phone call, or 3) to the control group who will not be enrolled in Annie.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study of Technology Assisted Depression Treatment Adherence
Actual Study Start Date : June 21, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AIMS Intervention
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
Behavioral: AIMS
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.

No Intervention: No Intervention
Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.
Experimental: AIMS Intervention Plus
Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
Behavioral: AIMS plus
Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.




Primary Outcome Measures :
  1. Proportion of Days Covered (pharmacy fill-based) [ Time Frame: 12 weeks ]
    The proportion of days covered (PDC) will calculate the ratio of the number of days the patient has possession of an antidepressant based on prescription fill date during the 12 weeks. The score ranges from 0 to 1, with 1 indicating 100% adherence.

  2. Change in medication adherence from baseline at 6 and 12 weeks [ Time Frame: Baseline, 6 and 12 weeks ]
    Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.


Secondary Outcome Measures :
  1. Change in depressive symptoms from baseline at 6 and 12 weeks [ Time Frame: Baseline, 6 and 12 weeks ]
    Patient Health Questionnaire (PHQ-9) - a standard instrument for measuring depressive symptom severity and monitoring treatment outcomes over time. A score of 4 or less indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 indicates severe depression.

  2. Change in medication side effects from baseline at 6 and 12 weeks [ Time Frame: Baseline, 6 and 12 weeks ]
    The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER): The 3-item FIBSER asks about the frequency, severity, and functional impact of antidepressant side effects using a 7-point Likert scale. The prevalence and distribution of scores for each domain will be compared across assessment time points.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

VA Patient

  • Diagnosed with depression
  • Initiating or changing to a new antidepressant medication
  • Cell phone with text messaging capabilities
  • Registered with My HealtheVet
  • Follow-up appointment with their provider in the next 12 weeks
  • Internet access
  • English speaking VA Providers: provide care to a study participant

Exclusion Criteria:

  • Lack of cell phone access/willingness to receive text messages
  • Diagnosis of cognitive disorders, psychotic disorders, bipolar disorder, or active substance abuse.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930849


Contacts
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Contact: Carolyn L Turvey, PhD MS (319) 338-0581 ext 7714 carolyn.turvey@va.gov
Contact: Dawn M Klein, MSW (319) 353-5690 dawn.klein@va.gov

Locations
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United States, Iowa
Iowa City VA Health Care System, Iowa City, IA Recruiting
Iowa City, Iowa, United States, 52246-2208
Contact: Bonnie J BootsMiller, PhD    319-338-0581 ext 4938    bonnie.bootsmiller@va.gov   
Contact: John E Holman, MA MA    (319) 338-0581 ext 7507    John.Holman2@va.gov   
Principal Investigator: Carolyn L Turvey, PhD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Carolyn L Turvey, PhD MS Iowa City VA Health Care System, Iowa City, IA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03930849     History of Changes
Other Study ID Numbers: PPO 18-111
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Depression
Patient Participation
Text messaging
Patient Portals
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders