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Social Media Navigation Aid Kits for Urinary Incontinence (SNAK)

Primary Purpose

Urinary Incontinence, Stress Incontinence, Female, Urge Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Media Navigation Aid Kit
Sponsored by
University of New Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Incontinence focused on measuring urinary incontinence, social media

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: New or existing patients to the Urogynecology practice at the University of New Mexico or Sandoval Regional Medical Center having urinary incontinence treatment options discussed/addressed by our provider group for the first time. Patients who report symptoms of urinary incontinence (defined as one or more episodes of involuntary urinary loss) Female >18 years old Willing to complete study questionnaires Exclusion Criteria: Age < 18 years Presence of urinary fistula Prior treatment of urinary incontinence Prior consult with a urogynecologist for urinary incontinence History of vaginal mesh complications Pregnancy or planning to become pregnant in the next 3-4 months during the study per patient report Cognitive impairment No access to internet at home Inability to speak/read/understand English

Sites / Locations

  • University of New MexicoRecruiting
  • Sandoval Regional Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine counseling

Routine counseling + Social Media Navigation Aid Kit

Arm Description

Patients randomized to routine counseling will receive usual counseling in the standard fashion of their provider.

Patients randomized to the intervention will receive routine counseling in the usual manner as well as receive access to the Social Media Navigation Aid Kit in the format of their choice (hardcopy via trifold, email, text, or QR code)

Outcomes

Primary Outcome Measures

Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS)
We will measure self-efficacy using the NIH Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS). The PROMIS raw scores are translated into a "T-score", which rescales and standardizes the score where the mean U.S. general population score is fixed at 50 points and SD fixed at 10.

Secondary Outcome Measures

Patient Global Impression of Improvement (PGI-I)
The Patient Global Impression of Improvement (PGI-I) is a validated 1-item questionnaire rating specific condition as perceived change in her condition in response to therapy for SUI. A lower score indicates better outcome.
Incontinence Severity Index (ISI)
The Incontinence Severity Index is a validated questionnaire that has been shown to correlate well with pad weighing tests. A lower index score at 3 months indicates clinical improvement/better outcome.
IIQ-7-SF
The Incontinence Impact Questionnaire is a validated questionnaire to assess the impact of the dysfunction on a patient quality of life. A lower IIQ-7-SF score at 3 months indicates better outcome/improvement.

Full Information

First Posted
April 24, 2023
Last Updated
May 18, 2023
Sponsor
University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT05858125
Brief Title
Social Media Navigation Aid Kits for Urinary Incontinence
Acronym
SNAK
Official Title
Social Media Navigation Aid Kits for Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare the effectiveness of a Urogynecology Social Media Navigation Aid Kit (SNAK) and routine counseling in the treatment of women with newly diagnosed urinary incontinence. The study will conduct a randomized controlled trial on treatment-naïve patients seeking care for urinary incontinence. The research will have five aims: evaluate the impact of SNAK on patients' self-efficacy in managing urinary incontinence symptoms compare patient satisfaction with urinary incontinence treatment between SNAK and routine counseling groups assess the impact of SNAK on urinary incontinence severity evaluate the impact of SNAK on patients' quality of life examine if there is an impact of SNAK on patients' treatment decision. Participants will be randomized to routine counseling alone versus routine counseling plus a SNAK. They will be given a baseline survey at their initial enrollment to the study. The investigators will follow up at a 3-month interval where they will be given a post-intervention survey.
Detailed Description
The objective of this research is to perform a non-masked, superiority randomized controlled trial to assess urinary incontinence (UI) symptoms of women newly diagnosed with UI before and after conservative treatment with either a Urogynecology Social Media Navigation Aid Kit or routine counseling. The target population are treatment naïve patients with urinary incontinence who are seeking care as a new patient. Our central hypothesis is that the addition of a Urogynecology Social Media Navigation Aid Kit will be superior to routine counseling alone in women with urinary incontinence. The investigators will recruit women with any type of urinary incontinence who present to the University of New Mexico Urogynecology practice at UNM Eubank Clinic (UNM) or Sandoval Regional Medical Center (SRMC). To confirm diagnosis and eligibility, The investigators will conduct a standard intake history and physical, complete with cough stress test, POP-Q pelvic examination, urinalysis, and urine culture. All potential participants will receive routine counseling about possible treatment options appropriate for her urinary incontinence, regardless of group assignment. Their follow up appointments will be the same regardless of participation in the study. The intervention is a Social media Navigation Aid Kit (SNAK) which was created by using search terms, "urinary incontinence", "urinary leakage", and "urogynecology", and querying various websites/blogs, Facebook, Instagram, and YouTube. These social media platforms were chosen based on the top three social media platforms used in Americans aged 50 to >65 years old according to Pew Research Analytics (Pew paper). The experienced reviewer evaluated each platform for users that provided relevant, accurate, and specific content. The department of Urogynecology at UNM independently reviewed the curated pages and users for approval. Once approved, the various users and pages were then collected and an infographic was created. The infographic will be available via hardcopy (as a trifold), email, text, and/or via QR code per patient preference. Potential subjects will be recruited in the UNM Eubank and SRMC clinics when they present for care for OAB/UUI, either in person or virtually via telephone or Zoom care visits. All patients will have a history and physical taken to determine their study eligibility. Recruitment will take place either in private exam rooms at these clinics or over HIPAA-compliant telephone or Zoom conversation. After recruitment, they will undergo the informed consent via the same means as recruitment and complete initial questionnaires in clinic or will be sent a copy (digital or mail) to read if enrolled virtually. The randomization sequence will be generated by computer-based randomization in a sequence that preserves 1:1 randomization and also preserves allocation concealment (likely with randomly alternating block sizes of 6-10 in blocked randomization). Randomization assignments will be completed via REDCAP by a research coordinator. Randomization will only occur after consent has been signed and all baseline data has been obtained. This is a single-center study at the University of New Mexico, and this site will recruit up to 75 patients. Outcomes collected: Data will be collected prospectively using a series of surveys. Our primary aim is to determine whether the participants have improved self-efficacy following the intervention based on the PROMIS Self-Efficacy for Managing Symptoms questionnaire at 3 months. The target population will be patients with urinary incontinence who are seeking care. If a patient is interested in this and fulfills study inclusion criteria then The investigators will offer her the choice of volunteering for the study. All women will give consent prior to their enrollment, after they have had time to carefully consider whether they want to participate in the study. Research staff and clinicians will obtain consent either in clinic or via zoom. After enrollment, participants will fill out baseline surveys including: Incontinence Severity Index (ISI), Patient-Reported Outcomes Measurement Information System for Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS), Incontinence Impact Questionnaire (IIQ-7-SF). At 3 months, patients will fill out the following surveys: ISI, PROMIS-SE-MCC-MS, PGI-I, IIQ-7-SF, and 3-month follow up questionnaire. If unable to contact the patient 3 times, The investigators will discontinue attempts and the patient will be considered lost to follow up. Data Analysis: Power analysis was performed based on previously reported minimally important change (MIC) of 2-6 points for PROMIS measures (26). The investigators will use the MIC of 2 points, divided by the expected SD of 10 points, giving us an effect size of 0.2. In order to examine the extent to which the score improves depending on the study arm assignment, repeated-measures ANOVA was used. To achieve significance for a non-inferiority study using these assumptions the investigators would need 50 patients, 25 per group to detect this difference with alpha =0.05 and with 80% power. To allow for a dropout of 20% the investigators will enroll at least 50 patients, but up to 75 to account for participants who are lost to follow up. Between and within group differences will be evaluated using Fisher's exact test for categorical variables and t-tests for continuous variables, as the investigators expect the data will be normally distributed. Wilcoxon rank-sum test will be used for continuous variables that are not normally distributed. If there are any baseline differences between groups, a multivariate analysis will determine the contribution of these differences to observed differences (if any) between groups Data Management/Confidentiality: Participants will be given a de-identified study subject number. Data collection sheets and questionnaires will contain the subject number. No other patient identifiers will be collected on study forms. PHI including patient name, date of birth, phone number, email address and medical record number will be collected to track appointments and ensure patient follow-up. The data collection, HIPAA and consent forms will be maintained via REDCap. PHI will not be entered into the study database. The link between PHI and study IDs will be kept on a password protected computer on a secure UNM OBGYN department server. The study database does not include sensitive information or information requiring additional protection. Electronic data entry will be performed on REDCAP, using the de-identified subject study number. The electronic data and subject link will be encrypted, password protected, and stored on the secure UNM OBGYN department server. This server's electronic security is monitored / maintained by the Health Sciences Library and Informatics Center (HSLIC). A REDCAP database will be created to collect, store and manage the data. REDCAP databases are reposed securely and all data entered is de-identified. The REDCAP database is only accessible using an individual unique login and password and access is only provided to co-investigators. Access is restricted to co-investigators and research staff and will be protected using the unique REDCAP login and password provided to each co-investigator. Access to the REDCAP will be restricted to research personnel and Investigators and will be locked or password-protected using the unique REDCAP login and password provided to each co-investigator. The data will be stored for 6 years after completion of analysis and study closure and then will be destroyed. A Certificate of Confidentiality will not be used to protect data from forced release. No identifying or study related data will be transported to outside locations. There will be no audio or video recordings or photographs taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Stress Incontinence, Female, Urge Incontinence
Keywords
urinary incontinence, social media

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine counseling
Arm Type
No Intervention
Arm Description
Patients randomized to routine counseling will receive usual counseling in the standard fashion of their provider.
Arm Title
Routine counseling + Social Media Navigation Aid Kit
Arm Type
Experimental
Arm Description
Patients randomized to the intervention will receive routine counseling in the usual manner as well as receive access to the Social Media Navigation Aid Kit in the format of their choice (hardcopy via trifold, email, text, or QR code)
Intervention Type
Other
Intervention Name(s)
Social Media Navigation Aid Kit
Intervention Description
The Social media Navigation Aid Kit (SNAK) was created by using search terms, "urinary incontinence", "urinary leakage", and "urogynecology", and querying various websites/blogs, Facebook, Instagram, and YouTube. These social media platforms were chosen based on the top three social media platforms used in Americans aged 50 to >65 years old according to Pew Research Analytics (Pew paper). The experienced reviewer evaluated each platform for users that provided relevant, accurate, and specific content. The department of Urogynecology at UNM independently reviewed the curated pages and users for approval. Once approved, the various users and pages were then collected and a flyer was created. The flyer will be available via hardcopy, email, or text per patient preference.
Primary Outcome Measure Information:
Title
Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS)
Description
We will measure self-efficacy using the NIH Patient-Reported Outcomes Measurement Information System for Self-Efficacy in Managing Chronic Conditions- Managing Symptoms (PROMIS-SE-MCC-MS). The PROMIS raw scores are translated into a "T-score", which rescales and standardizes the score where the mean U.S. general population score is fixed at 50 points and SD fixed at 10.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement (PGI-I)
Description
The Patient Global Impression of Improvement (PGI-I) is a validated 1-item questionnaire rating specific condition as perceived change in her condition in response to therapy for SUI. A lower score indicates better outcome.
Time Frame
3 month
Title
Incontinence Severity Index (ISI)
Description
The Incontinence Severity Index is a validated questionnaire that has been shown to correlate well with pad weighing tests. A lower index score at 3 months indicates clinical improvement/better outcome.
Time Frame
3 month
Title
IIQ-7-SF
Description
The Incontinence Impact Questionnaire is a validated questionnaire to assess the impact of the dysfunction on a patient quality of life. A lower IIQ-7-SF score at 3 months indicates better outcome/improvement.
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: New or existing patients to the Urogynecology practice at the University of New Mexico or Sandoval Regional Medical Center having urinary incontinence treatment options discussed/addressed by our provider group for the first time. Patients who report symptoms of urinary incontinence (defined as one or more episodes of involuntary urinary loss) Female >18 years old Willing to complete study questionnaires Exclusion Criteria: Age < 18 years Presence of urinary fistula Prior treatment of urinary incontinence Prior consult with a urogynecologist for urinary incontinence History of vaginal mesh complications Pregnancy or planning to become pregnant in the next 3-4 months during the study per patient report Cognitive impairment No access to internet at home Inability to speak/read/understand English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth T Hoang, MD
Phone
505-967-8428
Email
hsc-urogyn-research@salud.unm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra Darley
Phone
505-967-8428
Email
hsc-urogyn-research@salud.unm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasha Serna-Gallegos, MD
Organizational Affiliation
University of New Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoang
Phone
505-967-8428
Email
hsc-urogyn-research@salud.unm.edu
Facility Name
Sandoval Regional Medical Center
City
Rio Rancho
State/Province
New Mexico
ZIP/Postal Code
87144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hoang
Phone
505-967-8428
Email
hsc-urogyn-research@salud.unm.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Social Media Navigation Aid Kits for Urinary Incontinence

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