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.
RCT Entities:
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.
Authors: Suzanne Hagen; Carol Bugge; Sarah G Dean; Andrew Elders; Jean Hay-Smith; Mary Kilonzo; Doreen McClurg; Mohamed Abdel-Fattah; Wael Agur; Federico Andreis; Joanne Booth; Maria Dimitrova; Nicola Gillespie; Cathryn Glazener; Aileen Grant; Karen L Guerrero; Lorna Henderson; Marija Kovandzic; Alison McDonald; John Norrie; Nicole Sergenson; Susan Stratton; Anne Taylor; Louise R Williams Journal: Health Technol Assess Date: 2020-12 Impact factor: 4.014
Authors: Anne Martina Maria Loohuis; Huibert Burger; Nienke Wessels; Janny Dekker; Alec Gga Malmberg; Marjolein Y Berger; Marco H Blanker; Henk van der Worp Journal: BMJ Open Date: 2022-07-25 Impact factor: 3.006
Authors: Anne Mm Loohuis; Henk Van Der Worp; Nienke J Wessels; Janny H Dekker; Marijke CPh Slieker-Ten Hove; Marjolein Y Berger; Karin M Vermeulen; Marco H Blanker Journal: BJOG Date: 2022-05-31 Impact factor: 7.331
Authors: Anne M M Loohuis; Henk Van Der Worp; Nienke J Wessels; Janny H Dekker; Marijke C Ph Slieker-Ten Hove; Marjolein Y Berger; Karin M Vermeulen; Marco H Blanker Journal: BJOG Date: 2022-05-31 Impact factor: 7.331
Authors: Nienke J Wessels; Lisa Hulshof; Anne M M Loohuis; Lisette van Gemert-Pijnen; Petra Jellema; Henk van der Worp; Marco H Blanker Journal: JMIR Mhealth Uhealth Date: 2020-06-12 Impact factor: 4.773