Miami VA Healthcare System
Miami, Florida, 33125, United States
NCT Number: NCT02251054
This study compares the efficacy of embedding avatars into an online self-management program that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy, and adherence versus the same program without avatars
Looking for future studies?
Notify Me55 year and older
Female
Interventional
Not applicable
Miami, Florida, 33125, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials with Avatars.
We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials without Avatars.
Time frame: Baseline and at one, six, and 12 weeks
The OAB-q is a 33-item measure to assess impact of OAB symptoms on HRQOL. The OAB-q consists of a symptom bother scale and four HRQOL subscales (coping, concern, sleep, and social interaction). All scale scores are transformed to a 0-to-100-point scale, with higher symptom bother scores indicating greater symptom severity, and lower total and subscale scores indicating improvement in HRQOL.27 A 10-point change in these scales indicates a minimal clinically important difference (MCID). The Cronbach alpha coefficient in this study was 0.88.
Time frame: Baseline and at one, six, and 12 weeks
The PPBC is a single-item, six-point rating scale of participants subjective assessment of their bladder symptoms, with the question "My bladder causes…" me no (1), very minor (2), minor (3), moderate (4), severe (5), or many severe (6) problems. A two-point negative change indicates an MCID.28
Time frame: 12 weeks duration
Participants completed daily bladder diaries data for 12 weeks with information on date, beverage, quantity and time of fluid intake, voiding frequency, voiding volume quantified, urge-related episodes with or without urinary incontinence, and the circumstances of each episode. At each visit, research associates would review bladder diaries to ensure that entries were clear and interpretable. A research associate, blinded to group assignment, scored bladder diaries and managed the data.
Time frame: Baseline and at one, six, and 12 weeks
The GSEI measures older adults' level of confidence in preventing incontinence episodes. Total scores for the GSEI were computed by summing the scores from each of the 16 items (minimum 0, maximum 10 points per item, range 0-160); a minimum 20-point difference suggests an MCID. The Cronbach alpha coefficient in this study was 0.91.29 We also asked participants at baseline and at one, six, and 12 weeks to describe their confidence in doing pelvic floor muscle exercises: "How confident are you in doing pelvic floor muscle exercises?" and their ability to suppress urge: "How confident are you in suppressing the urge?" on a 100 mm visual analog scales (VAS). The 100 mm VAS was in the range of 0, "not at all confident" to 10, "extremely confident."
Time frame: Baseline and at one, six, and 12 weeks
Participants were asked how often they had performed PFME in the previous week (0=do not perform, 1=once a week, 2=twice a week once a day, 3=twice a week more than once a day, 4=alternate days once a day, 5= alternate day more than once, 6=every day of the week once a day, 7=every day of the week more than once a day). We also asked about the number of repetitions they did during each exercise session (0=1-2 times, 1=2-4 times, 3=4-6 times, 4=6-8 times, 5=8-10 times, 6=more than 10 times).
Time frame: At 12 weeks
The research associate asked participants if they recognized the face of the avatars in the tutorials at 12 weeks with a single question: "Who did the avatar look like?"
Miami VA Healthcare System
Fed
Acronym: OAB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05799313
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Cleveland, Ohio, United States
View Trial DetailsNCT05557279
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Maywood, Illinois, United States
View Trial DetailsNCT06198439
Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications
Houston, Texas, United States
View Trial DetailsNCT06206512
Cardiovascular Diseases, Female Urogenital Diseases
Dallas, Texas, United States
View Trial Details