eContinence; Development, evaluation, and implementation of treatment programmes for urinary incontinence via Internet/smartphone/PC tablet

Project description

eContinence; Development, evaluation, and implementation of treatment programmes for urinary incontinence via Internet/ smartphone/PC tablet

Background
Urinary incontinence (UI) is defined as “any urinary leakage” (Abrams_2002) by the International Incontinence Society (ICS). It is a common problem worldwide, and it is approximately twice as prevalent among women as in men (Milsom_2009). One-fourth of adult women have UI (Hannestad_2002). The prevalence and severity of UI increase with age and comorbidity (Hannestad, Rortveit et al. 2000; Milsom, Coyne et al. 2013). Urinary leakage may affect quality of life (QoL), (Monz_2007) and the costs of UI to society are large (Samuelsson_2001).
Stress urinary incontinence (SUI) is characterized by leakage on effort or exertion, or on sneezing or coughing. Urgency urinary incontinence (UUI) is characterized by leakage that is accompanied by or immediately preceeded by urgency (Abrams, Andersson et al. 2010). Mixed urinary incontinence (MUI) is a combination of the two. SUI accounts for 50% of UI in women, but is uncommon in men. UUI and/or MUI affect both men and women (Milsom, Coyne et al.2013). Overflow incontinence (OI) may occur in men that have outlet obstruction secondary to prostatic enlargement, but is uncommon in women (Abrams_2002)
Pelvic floor muscle training (PFMT) ic the first line of treatment for all main types of female UI (Abrams_2010, Nice_2006, Dumoulin_2010). Two-thirds of UI patients are improved or cured by this treatment, and it has no serious side effects (NICE_2006, Dumoulin_2010). PFMT is also effective in elderly patients (SBU_2013). Bladder training, a behavioural training that aims to help the individual to increase the interval between the desire to void and the actual void, can be combined with PFMT to treat MUI and UUI in both men and women (NICE_2006,). Continence is achieved for one-sixth of women with MUI/UUI treated with PFMT in combination with bladder training (Shamlyan et al 2012). Some studies also suggest that cognitive behavioural therapy (CBT) strategies increase QoL (Dowd_2000) and reduce the number of weekly leakage episodes (Garley_2006) in patients with UI. Lifestyle changes, such as weight loss for the obese and reduced intake of caffeinated drinks or other fluids (if intake is high), have shown beneficial effects in the treatment of UI ( NICE 2006; Abrams, Andersson et al. 2010) All of these first-line treatment options can be provided in primary health care.
It is unclear exactly how PFMT should be delivered to be most effective (Nice_2006, Dumoulin_2011). A Cochrane report from 2011 suggests that supervised training might be the best approach (Hay-Smith_2011), while a 2012 US review concludes that there are no significant differences between self-completed and supervised PFMT with regard to the likelihood of improving symptoms, improving QoL, achieving continence, or the rates of treatment failure and discontinuation (Shamliyan_2012). Thus, there is a need to compare different approaches to providing PFMT (Duet_2011). The development of new, easily accessible ways to provide non-pharmacological treatment has been identified as an important research field (Shamliyan_2012).
Although there are effective therapies, many individuals with UI refrain from seeking care (Hannestad_2002), sometimes because of embarrassment or shame (Kinchen_2003), Hagglund_2007). Furthermore, access to care for this condition is variable, and treatment is not always optimal after having sought care (Shaw_2006). In the elderly population, health care personnel often have pessimistic and low expectations of UI treatments (Teunissen_2006). A recent report from the Swedish Council on Health Technology Assessment requests more research on how to improve the assessment and treatment of UI in the elderly and frail elderly population (SBU_2013).

Assessment of UI in women
Assessment of women with UI includes the exclusion of underlying causes, such as symptoms of malignancy in the pelvic region, neurological disease, poor bladder emptying, or urinary tract infection (Shamliyan_2012, NICE_2006). Clinical evaluation with validated tools is the basis for diagnosis of UI type and severity, as well as its impact on QoL, and the treatment outcome should be evaluated based on what patients report in these validated tools and scales during follow-up (Shamliyan_2012). SUI can be diagnosed by history alone (NICE, Abrams_2010, Shamlyan_2012).

UI in men
In men, UI often appears together with changes in the prostate, or after prostate surgery. One year after they underwent radical prostatectomy to treat cancer, 16% of patients reported incontinence (Donellan_1997). One-third of men that were continent before surgery reported some leakage after transurethral retropubic prostatectomy (TURP). The assessment of men with UI always includes a rectal examination, a urinary sample, and a prostate-specific antigen (PSA) test. Recently, a systematic review has shown that preoperative PFMT reduce the risk of UI in men after TURP, but the value of PFMT to treat post-prostatectomy incontinence after radical prostatectomy remains uncertain (Campbell_2012). UUI and OAB are treated in the same way in men and women.

Technology advances and new ways to deliver treatment
In 2012, 94% of the Swedish population had access to a computer with an Internet connection, and 80% used the Internet on a daily basis. While virtually everyone aged 16-24 years has Internet access at home, 79% in the age group 65-74 years report the same. Additionally, Internet access is higher among those with higher income and education (SCB_2013). Among the populace with any physical impairment, 70% state that their impairment does not hinder Internet use. (SCB_2014). Compared with other nations, Swedish Internet usage statistics are high. It is common to seek health information online and women are more likely than men to seek health information online (Fox_2013), especially regarding issues that are perceived as embarrassing (Umefjord_2003).
Smartphone sales have increased rapidly in the last couple of years, and 75% of all cell phones sold are smartphones Overall, 63% of adults in Sweden own a smartphone. Ninety percent of cell phone owners use their phone to access the Internet on a daily basis (designmobile.se). An estimated 83-86% of 16- to 44-year-olds have accessed the Internet using a smartphone, compared with only 5% of 75- to 85-year-olds (SCB_2014).
Tablet computers generally have a simple, often intuitive, interface. Older people may find it easier to read text from a tablet PC than a printed book, possibly because of better contrast and the opportunity to increase the text size (Kretzschmar_2013).
Internet-based treatments have been developed for several conditions (Andersson_2011) and Internet-based cognitive behavioural therapy for depression, social phobia, and panic disorder is considered well established (Hedman_2012). The Internet is a useful tool for communication with patients with stigmatized illnesses (Berger_2005), and the barrier to seeking Internet-based care appears to be lower than for ordinary care. Patients perceive the treatment form as convenient, accessible, and time-sparing (Sanchez-Ortiz_2011). Good cost-effectiveness has been established for the Internet-based treatment of SUI (Sjöström_2013), depression, social phobia, and panic disorders (Hedman_2012).
Health care systems face great challenges, and clinicians must deliver treatment in cost-effective and affordable ways. Increasing self-management and patient empowerment might be one way to meet future demands, and Internet-based interventions are increasingly used to enhance patient empowerment among individuals with various chronic conditions (Calvillo_2013, Kuijpers_2013). Both empowerment and shared decision-making have been shown to render better health outcomes (Mola_2013, Schulz_2013). Women from Northern Europe with UI are especially prone to participate in shared-decision making and take an active role in their treatment, compared with women from 15 European countries (O´Donnell_2007).
In addition to adding value for the individual patient, Internet-based treatments for UI have the potential to reduce the need for support from the health care system, and help save its resources for those with implicit needs. Thus, it could reduce the demand on the primary care system while increasing both access to care and the quality of care given to this group of patients.

An Internet-based treatment programme for SUI
Our first study, granted by FAS 2008-0952, was a randomized controlled trial (RCT) that compared the effects of an Internet-based treatment programme for SUI versus a treatment programme sent by post. Both programmes were developed by us, and were based on 3 months of PFMT. A total of 250 women with SUI ≥1/week were recruited through our website and randomised to one of the programmes. Diagnosis was based on validated questionnaires, a two-day bladder diary, and a telephone interview with an urotherapist. We had no face-to face contact with the study participants. Treatment outcome was evaluated after 4 months with intention-to-treat (ITT) analysis. The RCT was registered at www.clinicaltrial.gov (ID: NCT01032265), and reported according to the CONSORT guidelines.
After treatment, we telephoned a strategic selection of participants to interview them about their experiences, and analysed the results according to grounded theory principles. We also performed a cost-utility analysis with a 1-year societal perspective, comparing the treatment programmes with each other and with a non-treatment alternative. Our results have been reported in detail in international medical journals (Sjöström_2012, Sjöström_2013, Sjöström_2013, Björk_2014), as well as in the 2014 thesis by Sjöström.
We have demonstrated that it is possible to manage SUI without face-to-face contact. Participants in both Internet- and post-based treatment groups achieved highly significant and clinically relevant improvements comparable to those observed in studies of supervised PFMT. Treatment effects on symptom severity and QoL were similar with both programmes; however, women receiving Internet-based treatment reported greater subjective improvements, larger reductions in the use of incontinence aids, and greater satisfaction with the treatment programme.
The interviews yielded that the study treatments seemed to lower the barrier for seeking care. Despite the lack of face-to-face contact, a supportive patient-provider relationship developed between participants in the Internet group and the urotherapist, and the participants felt acknowledged and supported without exposure. They gained greater knowledge of how to handle their situation, and felt empowered. The cost-utility analysis revealed that the Internet-based treatment programme is cost-effective compared with the postal programme and with a non-treatment alternative. The cost of delivering the treatment was lower than that of much ordinary care provided today.
Our overall conclusion is that Internet-based treatment for SUI is a new, acceptable, and affordable first-line treatment for SUI. It has the potential to increase access to care for this group of patients, and to empower women to take an active role in their health care.
During 2014, we will employ ITT analysis to examine the long-term effects of the treatment programmes (2 years) and determine predictors of a positive outcome.

A smartphone-based treatment programme for SUI
We have also developed a smartphone application supported by Android and iOS that provides information, advice on lifestyle, and a PFMT programme in six basic and six advanced levels. It contains help functions, as well as reminders, visualization of each level of training, and a statistics function. In an ongoing RCT, we compare the effects of immediately administered versus postponed PFMT provided with this smartphone application. The study is registered at www.clinicaltrials.gov (ID NCT01848938).
We have recruited 120 adult women (≥18 years of age) with ≥1 episode of SUI per week. Eligible women are randomised to 3 months of PFMT provided as a smartphone application, or to a group that will be offered the application after the first follow-up. Recruitment is complete, and treatment is ongoing, results will be analysed november-december 2014 A qualitative study exploring women’s experiences of PFMT for SUI administered through a smartphone application is also ongoing. One of the specific aim is to explore the women´s experiences of the application and their suggestions for improvements of the application.
This study is partly financed by FAS 2008-0952. The results will be presented as two articles in international medical journals.

The ACKTUS platform
We plan to translate the Internet-based programme into the terminology model of the Activity-Centered Modeling of Knowledge and Interaction Tailored to users (ACKTUS) platform in collaboration with Dr. Helena Lindgren at the Department of Computing Science, Umeå University. This system enables an advanced individual decision support for the user. The platform has been used to support individual doctor´s with decision support for diagnosis of dementia and possible interventions (Lindgren_2011; Lindgren H_2011). The platform is user-friendly both for study participants and researchers and it is possible to make alterations in the programmes without having advanced technological knowledge (Lindgren H_2013). Selected evaluation instruments will be digitalised and integrated into the programme.

Validated symptom and quality of life outcomes
The ICIQ-UI SF is a highly recommended,(NICE_2006, Shamliyan_2012, Hilton_2011) validated,(Avery_2004) and frequently used questionnaire that measures symptom severity. It comprises three scored items on frequency, amount, and overall bother of the leakage. The total score is 0-21, with higher values indicating greater symptom severity.
The ICIQ-LUTSqol is a highly recommended,(NICE_2006, Shamliyan_2012, Hilton_2011) and validated(Kelleher_1997, Coyne_2010, Sjöström_2012) questionnaire that assesses different aspects of everyday life that might be affected by the leakage. Each item is scored 1-4 (Never/Sometimes/Often/All the time). The total score range is 19-76, and higher values indicate greater impact on QoL.
The PGI-I is a validated (Yalcin_2003) questionnaire that asks the participant to rate her condition after treatment compared with before treatment. There are seven answer alternatives ranging from very much better to very much worse. We have defined the Minimal Important Detectable Difference (MID) for a clinically relevant outcome of the symptom and QoL scoring instrument that we use (ICIQ-UI SF and ICIQ-LUTSqol) in our population (Nyström E_2014).

Gender perspective
UI is more prevalent in women. During our first studies, many men have contacted us with questions about easily accessible treatment programmes for men with UI. There is a need for more studies of conservative treatment of UI in this group.

Overall and specific aims with this application
The overall aim of the www.econtinence.se project is to develop, evaluate, and implement assessment and treatment programmes for UI via Internet, smartphone, and PC tablet applications.

The specific aims are as follows:

1. To implement the Internet-based and postal treatment programmes for women with SUI in Sweden and the Netherlands, and to study treatment effects and patient preferences regarding care in different settings and cultural contexts.

What are the effects of the programmes when implemented in a clinical setting in comparison with the effects in the RCT? Why do women choose this kind of treatment? Do the effect and patient preferences differ between Sweden and the Netherlands?

Methods Study 1
This study will be performed in collaboration with Professor Toine Lagro-Janssen and Dr. Doreth Teunissen of the Department for Primary and Community Care, Radboud University, Nijmegen, The Netherlands.
The existing Internet-based programme will be translated into the ACKTUS platform, in both Swedish and Dutch. We aim for a user-friendly, and simple design, allowing for women with different backgrounds to use the platform. In both countries we will launch and promote an open access website, where women can self-diagnose SUI and be offered a a choice of treatment with either the Internet-based or the postal treatment programme. Women diagnosed with SUI within the ordinary health care system could also be referred to the website for treatment.
Baseline data will be collected, including demographics, location, perception of access to care, previous experiences of UI care, symptom severity (ICIQ-UI SF), and QoL (ICIQ-LUTSqol), and use of incontinence aids, in each country. Exclusion criteria will be: pregnancy, previous UI surgery, known malignancy in the lower abdomen, difficulty passing urine, macroscopic haematuria, intermenstrual bleeding, severe psychiatric disorder, and neurological disease affecting sensibility in the legs or lower abdomen. The treatment time will be 3 months.
Follow-up will be performed after 4 months, and will include outcome measures of symptom severity (ICIQ-UI SF), QoL (ICIQ-LUTSqol), the PGI-I, use of incontinence aids, and patient satisfaction. The follow-up questionnaire will also include open-ended questions to collect feedback and suggestions of potential improvements of the website and the treatment programmes. Furthermore, some participants might be telephone interviewed for additional feedback on how to increase the user-friendliness.
The effects of the treatment programmes will be evaluated within each country, and compared between the countries. Patients’ preferences will also be evaluated within and between the countries. The demographic differences and differences in access to care between the two countries will be used to investigate further what factors influence women’s choice of treatment.
The results will be presented as one or two articles in international medical journals.
Potential future developments of the programmes include translation to other languages spoken in the two countries, for example Arabic, Somali, or Kurdish. We also plan to update the website and the treatment programmes according to the feedback from the users.

Time frame study 1
The planning of this study has started, and our collaborators in the Netherlands have applied for funding for their part of the study. The Internet-based programme has been translated to Dutch, and contractual agreements have been made with the illustrator. During 2014 we plan to translate the programme to the ACKTUS platform, develop the baseline and follow-up questionnaires, perform sample size calculations, and apply for ethical approval. During 2015 we plan to launch the website, and start recruiting participants. Follow-up will be performed 2015/2016. Analysis of data, writing of articles, and publication 2016-2018.


2. To develop an integrated, personalized treatment programme based on bladder straining and pelvic floor muscle training that is accessible through Internet/smartphone/PC tablet applications, and to evaluate the effects of this treatment programme on MUI and UUI in women (RCT, three arms).

What are the effects of a complex treatment programme for UUI and MUI with increasing complexity and intensity in comparison with postponed treatment? What factors predict a positive outcome? Are the programmes cost-effective? How do women describe their experiences?

Methods study 2
The treatment programme includes PFMT, bladder training in six to eight steps or modules, and elements of CBT. It will be modelled on the ACKTUS platform, and a suitable user interface will be designed. Support for self-assessment, diagnosis, and selection of treatment can be implemented. The study will be registered at www.clinicaltrials.gov and reported as intention-to-treat in accordance with CONSORT guidelines.
We are aiming to recruit 120 women (≥18 years old) that experience ≥1 episode of MUI or UUI per week. Study participants will be recruited via the Internet and from primary and secondary care centres. Diagnosis will be based on questionnaires, a bladder diary, a telephone interview, and if necessary, a clinical assessment performed at each centre. Exclusion criteria will be newly developed symptoms of urgency (<6 months), painful urgency, haematuria, recurrent urinary tract infections, pregnancy, previous ui surgery, severe psychiatric disorder, and neurological disease affecting sensibility in the legs or lower abdomen. our power calculations are based on calculations from the findings in the internet study (iciq ui sf, pgi) and we expect an improvement in the postponed treatment group as a “study effect”. we are aiming for a 80% power and a two-sided significance level of 0.05, allowing a dropout level of 20-25. thus, we need 60 persons in each group. eligible participants will be randomised to one of the two following alternatives: 1) treatment based on pfmt and bladder training with increasing complexity and intensity, and elements of cbt 2) postponed treatment and after the first follow-up, treatment as in 1). the treatment time will be 12-16 weeks. outcomes will be symptom severity (iciq-ui sf), condition-specific qol (iciq-lutsqol),the iciq-fluts (brookes_2004), the pgi-i, incontinence episode frequency, use of incontinence aids, health economic measures, and patient satisfaction. the outcomes will be compared within, and between groups. follow-up will be performed after 4 months and 1 year. the women´s experiences of the programme will be evaluated with telephone interviews and free-text answers in a questionnaire. if the results from the rct are positive we aim to implement this programme and translate it into different languages. before implementation, necessary improvements will be done based on the participants experiences.the results will be published as three to four articles in international medical journals.>

Time frame study 2
Development of a diagnostic and a treatment programme for UUI and MUI during autumn 2014. During 2015 we will translate it into the platform and create the evaluation instruments. Recruitment continuously september 2015-december 2016. Analysis and writing 2017. If the results are positive the programmes will be implemented in different languages during 2018.


3.To develop and evaluate an integrated, personalized Internet/smartphone/PC tablet-based treatment programme for UI in men that have been diagnosed and assessed at a urology clinic or in primary care (pilot study, male cohort).

Methods study 3
The programme constructed in Study 2 will be further developed and adjusted to suit the treatment of men with UI in clinical practice. The male programme will be used in a pilot study at a urology clinic and in three different primary health care centres (n=30). Diagnosis will be based on the clinical assessment performed at each centre, which will include a bladder scan, a rectal examination of the prostate, a urinary sample, a bladder diary, and a blood sample. The exclusion criteria for this study will be untreated malignancy, painful urgency, haematuria, recurrent urinary tract infections, severe psychiatric disorder, and neurological disease affecting sensibility in the legs or lower abdomen. The programme will contain information, lifestyle advice, and a bladder-training programme. Outcomes will be assessed with validated tools, and will include symptom severity (ICIQ-UI SF), condition-specific QoL (ICIQ-LUTSqol), ICIQ-MLUTS, IPSS, the PGI-I (Yalcin_2003), frequency of incontinence episodes, use of incontinence aids, and patient satisfaction. The outcomes will be compared before and after treatment, and a strategic sample of men will also be interviewed about their experience of this treatment.

Time frame study 3
Jan-June 2016 Development of the programme. September 2016-August 2017 Pilot study
September 2017-July 2018 Analysis and writing

The research group
Associate professor Eva Samuelsson is the initiator of and the principal investigator in the research project www.econtinence.se (In Swedish: www.tät.nu). It was funded in 2008, with grants from The Swedish Council for Working Life and Social Research (grant ID: FAS 2008-0952). In addition, the project has received grants from the Jämtland County Council, the Swedish Society of Medicine, the Västerbotten County Council (ALF), and Visare Norr, Northern County Councils, Sweden.
Our research group originally comprised experienced general practitioners (GPs) (Göran Umefjord, MD PhD), urotherapists (Annika Andreasson, physiotherapist; Eva Källström, nurse midwife), and psychologists (Prof. Gerhard Andersson and Prof. Per Carlbring) with broad knowledge on the topics of UI and Internet-based treatments. GP Malin Sjöström completed her PhD thesis within the project, and is continuing work on the project as a postdoctoral researcher. She spent a research month at Nijmegen university and the the implementation study is now planned in collaboration with prof Toine Lagro Jansen. In addition, the group has expanded to include statisticians (Prof. Hans Stenlund) and a health economist (Prof. Lars Lindholm). The group now also includes an urologist (Lars Malmberg, MD PhD) a urotherapist (Karin Stenzelius, Nurse, PhD) as well as a gynaecologist from Örebro University Hospital (Karin Franzen MD PhD). The three latter and ES were all experts in the health technology assessment group for urinary incontinence in the elderly. One GP (Ina Asklund, MD), and one intern doctor (Emma Nyström, MD), are just about to begin their PhD studies within the project. We have started a collaborative endeavor with computer scientists and interaction designers at the Department of Computer Science at Umeå University (Associate Prof. Helena Lindgren) Our project coordinator research assistant Susanne Johansson will continue to administrate the studies.

Statistics
All statistical analyses will be performed in collaboration with experienced statisticians. Data will be collected in and analysed with IBM-SPSS (IBM, Armonk, NY, USA). We will use other programmes as needed, such as R or Excel (Microsoft Corporation, Redmond, VA). The analysis will be ITT, using all available data. For baseline comparison of groups, we will use Student’s t-test or an ANOVA model for continuous variables. For categorical variables, we will use the chi-squared test or Fisher’s exact test, as applicable. We will use paired t-tests to assess treatment effects within groups. To compare treatment effects between groups, we will use a mixed model analysis. If data is not symmetrically distributed, we will use non-parametric methods. We will consider P<0.05 statistically significant.>

Ethics
We have received ethical approval from the Regional Ethical Review Board of Umeå University for the Internet study (number 08-124M), as well as for the smartphone study (number 2012-325-31M). The ethical approval cover parts of study 1 and 2 in this application We will apply to the same entity for additional ethical approval for the studies. All enrolled study participants have provided or will provide informed consent, and we will give no reimbursements. All data will be stored according to the Personal Data Act (1998).
The RCTs will be registered at www.clinicaltrials.gov and reported according to the CONSORT guidelines.
We will publish our results in international medical journals. In addition, we will continuously publish parts of the results in lay language at our website, to allow the participants to partake of them. To provide secure communication over the Internet, the Internet-based programmes and the smartphone applications will be built on secure platforms using two-factor authentication and Secure Sockets Layer.


Implementation plan
The smartphone application will be available at Appstore and Market in 2015 (free of charge).
The broschure from our first study will be available at our website as pdf during 2015
The implementation of the Internet programme start during 2015
If the results are positive from the study of MUI and UUI, we will make them available as soon as the results are analyzed.



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Key words: urinary incontinence eHealth, mHealth, randomized controlled trial, qualitative methods