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Evaluating Treatment Continuation in Telehealth Patients Receiving an Automated Patient-Reported Outcome Tool

R

Ro

Status

Completed

Conditions

Erectile Dysfunction
Internet-based Intervention
Telemedicine
Online Intervention
Web-based Intervention

Treatments

Other: An automated patient-reported outcome data collection and adverse event surveillance tool

Study type

Interventional

Funder types

Industry

Identifiers

NCT05895539
21-12-196-599

Details and patient eligibility

About

Engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (AE) data. Collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence.

This study evaluated whether implementing a patient-reported outcome data collection and AE surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. We evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. We tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.

Enrollment

2,000 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male patients living in the US, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (PDE-5) inhibitors as treatment

Exclusion criteria

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,000 participants in 2 patient groups

Control
No Intervention group
Description:
Did not receive the tool
Intervention
Experimental group
Description:
Did receive the tool
Treatment:
Other: An automated patient-reported outcome data collection and adverse event surveillance tool

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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