NCT04911426: (T-CAP)

Telehealth-Clinical Advocacy Project

Completed NA Results posted Last updated 18 April 2025

What this trial tests

NA trial testing Telehealth in Substance Use in 8 participants. Completed in 31 July 2023.

Timeline

14 June 2021

Primary endpoint
31 July 2023

31 July 2023

Quick facts

Lead sponsor	Texas Christian University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	8
Start date	14 June 2021
Primary completion	31 July 2023
Estimated completion	31 July 2023
Sites	1 location across United States

Drugs / interventions tested

• Telehealth

Conditions studied

• Substance Use — all drugs for Substance Use →

Sponsor

Texas Christian University

Who can join

18 and older, any sex, with Substance Use. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Participants Who Received One or More Referrals During the 12-week Intervention. Primary · 12-week intervention period

The number of participants who received one or more referrals to services made by the intervention coach. This measure is collected as evidence supporting participant utilization of the app and the coaching support model.

Group	Value	95% CI
Treatment Plus Telehealth	4

Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 Primary · Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.

The Texas Christian University Drug Screen 5 is a 19-question survey that captures substance use during the past 12 months. Interpretation of the TCU Drug Screen 5 score for drug use severity corresponds with the Diagnostic and Statistical Manual of Mental Disorders 5 criteria for reporting three possible severity levels (mild, moderate, severe). A single level score is based on participant responses to 11 items (total range: 0 to 11) as such: the presence of 2 to 3 endorsed symptoms is scored as a mild disorder; 4 to 5 endorsed symptoms is scored as moderate disorder; and a severe disorder is

TCU Drug Screen Baseline scores

Group	Value	95% CI
T-CAP Study Sample	9.25	0 – 11

Post intervention TCU Drug Screen Scores

Group	Value	95% CI
T-CAP Study Sample	9.75	0 – 11

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for a period of 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Plus Telehealth

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (2 terms — click to expand)

Reaction	System	Treatment Plus Telehealth
Kidney stones	General disorders	—
Medical procedure	General disorders	—

Data from ClinicalTrials.gov NCT04911426 adverse events section.

Sponsor's own description

The purpose of this study is to develop a clinical telehealth intervention and test the feasibility of integrating telehealth within a police opioid county diversion program.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.