Clinical trial NCT03930849: Pilot Study of Annie Text Messaging for Depression Treatment Adherence
Official title: Pilot Study of Technology Assisted Depression Treatment Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Patient Participation
Text messaging
Patient Portals
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-04-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Medication Adherence at Baseline, 6 Weeks and 12 Weeks
timeFrame: Baseline, 6 and 12 weeks
Secondary outcomes:
measure: Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
timeFrame: Baseline, 6 and 12 weeks
measure: Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
timeFrame: Baseline, 6 and 12 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Iowa City VA Health Care System, Iowa City, IA
state: Iowa
Study officials:
affiliation: Iowa City VA Health Care System, Iowa City, IA
name: Carolyn L Turvey, PhD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Tiem J, Moeckli J, Suiter N, Fuhrmeister L, Pham K, Dindo L, Turvey C. "A link to the outside:" Patient perspectives on a mobile texting program to improve depression self-management. Patient Educ Couns. 2021 Sep;104(9):2154-2158. doi: 10.1016/j.pec.2021.02.018. Epub 2021 Feb 11.