A Telehealth Intervention to Increase Patient Preparedness for Surgery in Latinas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
There are 3 aims of this study. In Aim 1 community patient partners will be enrolled to help guide the research being performed in all of the aims. Investigators will also administer a survey that will help determine factors associated with surgical preparedness. In Aim 2 investigators will develop an intervention to increase surgical preparedness using Human Centered Design Methods. Aim 3 will pilot test the intervention using mixed methods to determine feasibility and implementation outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Self-report as female
18 years and older
Self-report as Hispanic ethnicity
Scheduled to undergo a surgery for a urogynecologic condition in the operating room (surgery to correct pelvic organ prolapse, urinary/fecal incontinence, fistula, urethral masses)
Disqualifiers
Self-report as male
Are less than 18 years of age
Self-report as not of Hispanic ethnicity
Scheduled to undergo a surgery for a condition that is not urogynecologic or is not in the operating room
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth intervention
BehavioralThis telehealth intervention will be made using human centered design methods
Treatment groups
357 Participants
are divided into 2 treatment groupsGroup A: Routine Preoperative CounselingNo intervention 0 interventions
Group B: Telehealth interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of the Intervention
A feasible study will be defined a 1) \>4 on 1-5 Likert-type scales of acceptability, appropriateness, and feasibility; 2) \>70% for adherence; and 3)\> 90% for dose delivery, and percent completed intervention. Acceptability will be measured by the Acceptability of the Intervention Measure Appropriateness will be measured by the Intervention Appropriateness Measure Feasibility will be measured by the Feasibility of Intervention Measure
Time frame
Day of Surgery, before surgery, in the preoperative holding2
Acceptability of the Intervention
As measured by the Acceptability of the Intervention Measure
Time frame
Day of Surgery, before surgery, in the preoperative holding3
Appropriateness of the Intervention
As measured by the Intervention Appropriateness Measure
Time frame
Day of Surgery, before surgery, in the preoperative holdingSecondary outcomes
1
Surgical Preparedness
As measured by the Surgical Preparedness Assessment survey
Time frame
Day of Surgery, before surgery, in the preoperative holding2
Health Literacy
As measured by the Brief Health Literacy Screen
Time frame
Preoperative Visit, before surgery3
Self-Efficacy
As measured by the General Self-Efficacy Scale
Time frame
Preoperative Visit, before surgery4
Trust in Provider
As measured by the Trust in Provider Scale
Time frame
Preoperative Visit, before surgeryOther outcomes
1
Demographics
Baseline Case Report Form
Time frame
Preoperative Visit 6-8 weeks after surgery2
Surgical Data
Surgical Case Report Form
Time frame
Day of Surgery, before surgery, in the preoperative holding3
Adverse Events
Adverse Events Case Report Form
Time frame
Postoperative Visit 6-8 weeks after surgery4
Symptom Bother - PFDI 20
As measured by the Pelvic Floor Distress Inventory-20
Time frame
Preoperative Visit, before surgery and Postoperative Visit 6-8 weeks after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Alabama at Birmingham
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov