Trial Outcomes & Findings for Telehealth-Clinical Advocacy Project (NCT NCT04911426)

Last Updated: 2025-04-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

12-week intervention period

Results posted on

2025-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Plus Telehealth Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The sample size at baseline (N=8) in the analysis reflects that number of participants in the group who experienced the telehealth plus coaching intervention (n=6) and participants (n=2) who did not receive the intervention.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Plus Telehealth n=8 Participants Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
Number of Participants Completing the Texas Christian University Drug Screen 5 Data	8 participants n=5 Participants • The sample size at baseline (N=8) in the analysis reflects that number of participants in the group who experienced the telehealth plus coaching intervention (n=6) and participants (n=2) who did not receive the intervention.

PRIMARY outcome

Timeframe: 12-week intervention period

Population: Six of eight consented participants (i.e., the intent-to-treat participants) completed calls with a coach, resulting in four participants (n=66.67%) who received referrals and two participants (n=33.33%) who did not receive a referral. The remaining two participants were not in the intent-to-treat group after randomization was discontinued.

Outcome measures

Outcome measures
Measure	Treatment Plus Telehealth n=6 Participants Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
Percent of Participants Who Received One or More Referrals During the 12-week Intervention.	4 Participants

PRIMARY outcome

Timeframe: Texas Christian University Drug Screen 5 data are reported for baseline and end-of-intervention at 12 weeks after consent.

Population: Four participants completed the Texas Christian University Drug Screen 5 at baseline and at the end of the intervention (12 weeks after consenting to the study).

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 scored with the presence of 6 or more symptoms of the 11 items; thus, more endorsed items means a more serious drug use problem.

Outcome measures

Outcome measures
Measure	Treatment Plus Telehealth n=4 Participants Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 TCU Drug Screen Baseline scores	9.25 score on a scale Interval 0.0 to 11.0
Texas Christian University Drug Screen 5 Severity Score From Baseline to Post Intervention at Week 12 Post intervention TCU Drug Screen Scores	9.75 score on a scale Interval 0.0 to 11.0

Adverse Events

Treatment Plus Telehealth

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Plus Telehealth n=8 participants at risk Individuals will receive telehealth support services, including seven brief motivational interviewing sessions, delivered by a licensed substance use counselor via live interactive video calls during the 12-week intervention. Telehealth: The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
General disorders Kidney stones	12.5% 1/8 • Number of events 1 • Adverse event data were collected for a period of 3 months. Definitions are consistent with Clinical Trials.
General disorders Medical procedure	12.5% 1/8 • Number of events 1 • Adverse event data were collected for a period of 3 months. Definitions are consistent with Clinical Trials.

Additional Information

Dr.Jennifer Pankow

Texas Christian University Institute of Behavioral Research

Phone: 8172577226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place