TY - JOUR
T1 - The impact of a mobile application-based treatment for urinary incontinence in adult women
T2 - Design of a mixed-methods randomized controlled trial in a primary care setting
AU - Loohuis, Anne M.M.
AU - Wessels, Nienke J.
AU - Jellema, Petra
AU - Vermeulen, Karin M.
AU - Slieker-ten Hove, Marijke C.
AU - van Gemert-Pijnen, Julia E.W.C.
AU - Berger, Marjolein Y.
AU - Dekker, Janny H.
AU - Blanker, Marco H.
N1 - Wiley deal
PY - 2018/9/1
Y1 - 2018/9/1
N2 - Aims: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. Methods: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI≥2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. Conclusion: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.
AB - Aims: We aim to assess whether a purpose-developed mobile application (app) is non-inferior regarding effectiveness and cost-effective when used to treat women with urinary incontinence (UI), as compared to care as usual in Dutch primary care. Additionally, we will explore the expectations and experiences of patients and care providers regarding app usage. Methods: A mixed-methods study will be performed, combining a pragmatic, randomized-controlled, non-inferiority trial with an extensive process evaluation. Women aged ≥18 years, suffering from UI≥2 times per week and with access to a smartphone or tablet are eligible to participate. The primary outcome will be the change in UI symptom scores at 4 months after randomization, as assessed by the International Consultation on Incontinence Modular Questionnaire UI Short Form. Secondary outcomes will be the change in UI symptom scores at 12 months, as well as the patient-reported global impression of improvement, quality of life, change in sexual functioning, UI episodes per day, and costs at 4 and 12 months. In parallel, we will perform an extensive process evaluation to assess the expectations and experiences of patients and care providers regarding app usage, making use of interviews, focus group sessions, and log data analysis. Conclusion: This study will assess both the effectiveness and cost-effectiveness of app-based treatment for UI. The combination with the process evaluation, which will be performed in parallel, should also give valuable insights into the contextual factors that influence the effectiveness of such a treatment.
KW - UT-Hybrid-D
KW - Mixed methods
KW - Mobile applications
KW - Randomized controlled trial
KW - Self-management
KW - Urinary incontinence
KW - Women
KW - EHealth
UR - http://www.scopus.com/inward/record.url?scp=85041335730&partnerID=8YFLogxK
U2 - 10.1002/nau.23507
DO - 10.1002/nau.23507
M3 - Article
AN - SCOPUS:85041335730
SN - 0733-2467
VL - 37
SP - 2167
EP - 2176
JO - Neurourology and Urodynamics
JF - Neurourology and Urodynamics
IS - 7
ER -