Video Directly Observed Therapy (VDOT) to Improve Medication Adherence

NCT03970642 | Terminated

• 1 other identifier: IRB 19-136-2
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the lack of human resources, it is impossible to monitor patients' medication adherence objectively or in-person by observation like tuberculosis programs worldwide do. The feasibility and patient acceptance of the innovative video-based directly observed therapy (VDOT) approach for improving medication adherence among tuberculosis patients has been demonstrated through studies in the United States as well as internationally (7). Medication adherence among VDOT users has been found to be comparable to in-person directly observed treatment (91% vs 95%) among patients in New York (8). In this clinical research project, we will test the feasibility, acceptance and effectiveness of an innovative mobile-based behavioral intervention to improve medication adherence and depression symptoms among patients suffering from depression.

Conditions

Depression

Keywords

video directly observed therapy

Outcome Measures

Primary Outcomes (1)

• Change in medication adherence

  The change in medication adherence during the study period will be determined using the ASK-20 questionnaire. The ASK-20 questionnaire includes 20 questions, each with a likert response from 1 to 5 with 1 representing excellent and 5 representing poor medication adherence.

  The questionnaire will be administered at baseline, 6 weeks and 3 months.

Secondary Outcomes (1)

• Change in depression symptoms

  The questionnaire will be administered at baseline, 6 weeks and 3 months.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group will receive individualized text reminders on their phone prior to each dose of their depression medicine. They will receive the video directly observed therapy smartphone app. Research staff will be able to monitor these medication adherence video on a password protected server linked to the app. Upto 50 patients will be randomly assigned to this group.

Other: Video directly observed therapy

Control

NO INTERVENTION

The control group will receive current standard of care. Upto 50 patients will be randomly assigned to this group.

Interventions

Video directly observed therapy OTHER

The intervention group will receive individualized text reminders on their phone prior to each dose of their depression medicine. They will be requested to use the VDOT smartphone app to make a video recording of each medication dose ingested during the 3 month study period following their first visit. The app will automatically upload the video to a HIPAA compliant server. Research staff will regularly monitor videos using a password protected website and document each medication dose.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will be English speaking
• \>=18 years old
• diagnosed with depression and currently prescribed oral antidepressant medication
• own a mobile phone and active phone plan capable of receiving text messages.

You may not qualify if:

• Non-English speakers, minors (\<18 years old)
• patients diagnosed with bipolar disorder (patient may be included if the study team determines that the historical diagnosis of bipolar disorder was inaccurate)
• visual or cognitive disabilities and/or terminal illness
• patients with any clinically significant medical or psychiatric condition, as deemed by the investigator, that can affect their ability to participate in the protocol, including primary psychotic disorder, and active suicidal intent or plan at the time of screening.

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health Psychiatry practice

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this randomized controlled trial, participants will be randomly assigned to the study or the control group. A total of up to 100 participants will be enrolled (50 participants assigned to each group).

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: May 31, 2019
• Study Start: May 27, 2019
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01

Locations

US (1)