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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05895539
Other study ID # 21-12-196-599
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 8, 2020
Est. completion date November 16, 2020

Study information

Verified date May 2023
Source Ro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 2000
Est. completion date November 16, 2020
Est. primary completion date November 16, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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: -

Study Design


Intervention

Other:
An automated patient-reported outcome data collection and adverse event surveillance tool
Patients received a short prompt to provide information on treatment satisfaction and side effects

Locations

Country Name City State
United States Ro HQ New York New York

Sponsors (1)

Lead Sponsor Collaborator
Ro

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 1 month Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve) 91 days
Primary Odds of refilling prescription and percent of patients who refilled prescription for patients with an initial auto-refill plan of 3 months Odds of refilling prescription (logistic regression); percent of patients who refilled prescription (log rank test from Kaplan Meier curve) 123 days
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