NCT03930849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 21, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 18, 2022

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

April 16, 2019

Results QC Date

September 28, 2021

Last Update Submit

July 19, 2023

Conditions

Keywords

DepressionPatient ParticipationText messagingPatient Portals

Outcome Measures

Primary Outcomes (1)

  • Medication Adherence at Baseline, 6 Weeks 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.

    Baseline, 6 and 12 weeks

Secondary Outcomes (2)

  • Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks

    Baseline, 6 and 12 weeks

  • Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks

    Baseline, 6 and 12 weeks

Study Arms (3)

AIMS Intervention

EXPERIMENTAL

Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.

Behavioral: AIMS

No Intervention

NO INTERVENTION

Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program.

AIMS Intervention Plus

EXPERIMENTAL

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

Interventions

AIMSBEHAVIORAL

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.

AIMS Intervention
AIMS plusBEHAVIORAL

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.

AIMS Intervention Plus

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292, United States

Location

Related Publications (2)

  • Turvey C, Fuhrmeister L, Klein D, McCoy K, Moeckli J, Stewart Steffensmeier KR, Suiter N, Van Tiem J. Secure Messaging Intervention in Patients Starting New Antidepressant to Promote Adherence: Pilot Randomized Controlled Trial. JMIR Form Res. 2023 Dec 8;7:e51277. doi: 10.2196/51277.

  • 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.

MeSH Terms

Conditions

DepressionPatient Participation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Results Point of Contact

Title
Carolyn Turvey, Ph.D.
Organization
Department of Veterans Affairs

Study Officials

  • Carolyn L Turvey, PhD MS

    Iowa City VA Health Care System, Iowa City, IA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 29, 2019

Study Start

June 21, 2019

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

July 27, 2023

Results First Posted

February 18, 2022

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Original VA funded datasets will be retained on VA servers behind VA firewalls. These data will be provided to interested parties following proper filing and verification of a FOIA request and approval by the Privacy Officer. These data will be maintained as required by VA data retention policies.

Locations