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A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease. OBJECTIVE:The objective of this study is to assess the safety and efficacy of self-initiated care assisted by a smartphone app in patients with RA. METHODS:This is a randomized controlled trial that will be performed for 1 year. A total of 176 patients with RA will be randomized to either self-initiated care with only one scheduled follow-up consultation assisted by our app or usual care. The coprimary outcome measures are the number of outpatient clinic consultations with a rheumatologist taking place during the trial period and the mean disease activity score as measured by the disease activity score 28 (DAS28) at 12 months. The secondary outcomes are patient satisfaction, adherence, patient empowerment, and cost evaluation of health care assisted by the app. RESULTS:Recruitment started in May 2019, and up to 18 months will be required for completion of recruitment. Thus far, 78 patients have been randomized, and thus far, experiences with the app have been positive. The study results are expected to be published by the end of 2021. CONCLUSIONS:The completion of this study will provide important data regarding the following: (1) safety of self-initiated care supported by a smartphone app in terms of DAS28 and (2) efficacy of lowering health care usage with this new strategy of providing health care. TRIAL REGISTRATION:Netherlands Trial Register NL7715; https://www.trialregister.nl/trial/7715. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15105.

SUBMITTER: Seppen BF

PROVIDER: S-EPMC7057822 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial.

Seppen Bart F BF L'ami Merel J MJ Duarte Dos Santos Rico Sharon S Ter Wee Marieke M MM Turkstra Franktien F Roorda Leo D LD Catarinella Fabio S FS van Schaardenburg Dirkjan D Nurmohamed Michael T MT Boers Maarten M Bos Wouter H WH

JMIR research protocols 20200219 2

<h4>Background</h4>Telemedicine based on self-measurement of disease activity could be one of the key components to create the health care system of the future. Previous publications in various medical fields have shown that it is possible to safely telemonitor patients while reducing the number of outpatient clinic visits. For this purpose, we developed a mobile phone app for patients with rheumatoid arthritis (RA), which allows them to self-monitor their disease.<h4>Objective</h4>The objective ...[more]

PMID: 32130182

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Project description:BackgroundSeveral mobile apps that monitor symptoms of rheumatoid arthritis (RA) exist, but a recent systematic review indicated that high-quality apps are lacking. When patients self-monitor their own disease with patient-reported outcomes (PROs) and self-initiate care at the right moment, it may be possible to reduce the frequency of their clinic visits, which would reduce health care burden and costs. We developed an app, that is, the MijnReuma Reade app, for this purpose and performed 2 pilot tests with weekly self-monitoring.ObjectiveThe primary objective of this study was to design, develop, and evaluate the usability, satisfaction, and usage of the MijnReuma Reade app-an app that allows patients with RA to monitor their own disease. The secondary objective was to review the patients' perspectives on app usage and its intended purpose.MethodsThis app was designed in collaboration with patients with RA, rheumatologists, and information technology experts. Two 1-month pilot studies were performed, after which satisfaction (0-10 scale), usability (system usability scale, 0-100), and usage (proportion of completed questionnaires) of this app were assessed. After the second pilot study, semistructured interviews were performed to determine patients' perspectives and the promoters and barriers of app usage.ResultsIn the first and second pilot study, 42 and 27 patients were included, respectively. Overall, the patients were satisfied (medians, 8 and 7) and found the app usable (mean system usability scores, 76 and 71) in pilot studies 1 and 2, respectively. App usage declined over time in both the pilot studies; 61% (17/28) and 37% (10/27) of the patients who disclosed their usage statistics completed the final weekly questionnaire in pilot study 1 and pilot study 2, respectively. Approximately 81% (25/31) of the patients indicated they would like to skip hospital visits if the self-monitored disease activity is low. In the semistructured interviews, technical problems, internal resistance (respondent fatigue, the app reminded them of their disease), and a lack of symptoms were identified as barriers for usage. Patients reported that "experiencing more grip on their disease" and "improved communication with their physician" were promoters for usage. Patients reported that pain positively mediated usage, that is, more pain promoted and less pain discouraged app usage.ConclusionsThis study illustrates the feasibility of the MijnReuma Reade app that enables self-monitoring of the disease activity in patients with RA with the overarching aim to allocate clinical consultations according to need. Satisfaction with the app and usability of the app were found to be high; however, app usage declined over time. Patients acknowledged the potential of the app to self-monitor their own disease and would like to be able to skip clinic visits if the monitored disease activity is low. To evaluate this strategy, a randomized controlled trial is underway.

Project description:ObjectivesTo determine whether direct access to hospital review initiated by patients with rheumatoid arthritis would result in improved clinical and psychological outcome, reduced overall use of healthcare resources, and greater satisfaction with care than seen in patients receiving regular review initiated by a rheumatologist.DesignTwo year randomised controlled trial extended to six years.SettingRheumatology outpatient department in teaching hospital.Participants209 consecutive patients with rheumatoid arthritis for over two years; 68 (65%) in the direct access group and 52 (50%) in the control group completed the study (P = 0.04).Main outcome measuresClinical outcomepain, disease activity, early morning stiffness, inflammatory indices, disability, grip strength, range of movement in joints, and bone erosion. Psychological status: anxiety, depression, helplessness, self efficacy, satisfaction, and confidence in the system. Number of visits to hospital physician and general practitioner for arthritis.ResultsParticipants were well matched at baseline. After six years there was only one significant difference between the two groups for the 14 clinical outcomes measured (deterioration in range of movement in elbow was less in direct access patients). There were no significant differences between groups for median change in psychological status. Satisfaction and confidence in the system were significantly higher in the direct access group at two, four, and six years: confidence 9.8 v 8.4, 9.4 v 8.0, 8.7 v 6.9; satisfaction 9.3 v 8.3, 9.3 v 7.7, 8.9 v 7.1 (all P < 0.02). Patients in the direct access group had 38% fewer hospital appointments (median 8 v 13, P < 0.0001).ConclusionsOver six years, patients with rheumatoid arthritis who initiated their reviews through direct access were clinically and psychologically at least as well as patients having traditional reviews initiated by a physician. They requested fewer appointments, found direct access more acceptable, and had more than a third fewer medical appointments. This radical responsive management could be tested in other chronic diseases.

Project description:Using smartphones to enroll, obtain consent, and gather self-reported data from patients has the potential to enhance our understanding of disease burden and quantify physiological impact in the real world. It may also be possible to harness integral smartphone sensors to facilitate remote collection of clinically relevant data.We conducted the Patient Rheumatoid Arthritis Data From the Real World (PARADE) observational study using a customized ResearchKit app with a bring-your-own-device approach. Our objective was to assess the feasibility of using an entirely digital approach (social media and smartphone app) to conduct a real-world observational study of patients with rheumatoid arthritis.We conducted this observational study using a customized ResearchKit app with a bring-your-own-device approach. To recruit patients, the PARADE app, designed to guide patients through a series of tasks, was publicized via social media platforms and made available for patients in the United States to download from the Apple App Store. We collected patient-reported data, such as medical history, rheumatoid arthritis-related medications (past and present), and a range of patient-reported outcome measures. We included in the assessment a joint-pain map and a novel objective assessment of wrist range of movement, measured by the smartphone-embedded gyroscope and accelerometer.Within 1 month of recruitment via social media campaigns, 399 participants self-enrolled, self-consented, and provided complete demographic data. Joint pain was the most frequently reported rheumatoid arthritis symptom to bother study participants (344/393, 87.5%). Severe patient-reported wrist pain appeared to be inversely linked with the range of wrist movement measured objectively by the app. At study entry, 292 of 399 participants (73.2%) indicated a preference for participating in a mobile app-based study. The number of participants in the study declined to 45 of 399 (11.3%) at week 12.Despite the declining number of participants over time, the combination of social media and smartphone app with sensor integration was a feasible and cost-effective approach for the collection of patient-reported data in rheumatoid arthritis. Integral sensors within smartphones can be harnessed to provide novel end points, and the novel wrist range of movement test warrants further clinical validation.

Project description:BACKGROUND:Self-monitoring of dietary intake is a valuable component of behavioral weight loss treatment; however, it declines quickly, thereby resulting in suboptimal treatment outcomes. OBJECTIVE:This study aimed to examine a novel behavioral weight loss intervention that aims to attenuate the decline in dietary self-monitoring engagement. METHODS:GoalTracker was an automated randomized controlled trial. Participants were adults with overweight or obesity (n=105; aged 21-65 years; body mass index, BMI, 25-45 kg/m2) and were randomized to a 12-week stand-alone weight loss intervention using the MyFitnessPal smartphone app for daily self-monitoring of either (1) both weight and diet, with weekly lessons, action plans, and feedback (Simultaneous); (2) weight through week 4, then added diet, with the same behavioral components (Sequential); or (3) only diet (App-Only). All groups received a goal to lose 5% of initial weight by 12 weeks, a tailored calorie goal, and automated in-app reminders. Participants were recruited via online and offline methods. Weight was collected in-person at baseline, 1 month, and 3 months using calibrated scales and via self-report at 6 months. We retrieved objective self-monitoring engagement data from MyFitnessPal using an application programming interface. Engagement was defined as the number of days per week in which tracking occurred, with diet entries counted if ?800 kcal per day. Other assessment data were collected in-person via online self-report questionnaires. RESULTS:At baseline, participants (84/100 female) had a mean age (SD) of 42.7 (11.7) years and a BMI of 31.9 (SD 4.5) kg/m2. One-third (33/100) were from racial or ethnic minority groups. During the trial, 5 participants became ineligible. Of the remaining 100 participants, 84% (84/100) and 76% (76/100) completed the 1-month and 3-month visits, respectively. In intent-to-treat analyses, there was no difference in weight change at 3 months between the Sequential arm (mean -2.7 kg, 95% CI -3.9 to -1.5) and either the App-Only arm (-2.4 kg, -3.7 to -1.2; P=.78) or the Simultaneous arm (-2.8 kg, -4.0 to -1.5; P=.72). The median number of days of self-monitoring diet per week was 1.9 (interquartile range [IQR] 0.3-5.5) in Sequential (once began), 5.3 (IQR 1.8-6.7) in Simultaneous, and 2.9 (IQR 1.2-5.2) in App-Only. Weight was tracked 4.8 (IQR 1.9-6.3) days per week in Sequential and 5.1 (IQR 1.8-6.3) days per week in Simultaneous. Engagement in neither diet nor weight tracking differed between arms. CONCLUSIONS:Regardless of the order in which diet is tracked, using tailored goals and a commercial mobile app can produce clinically significant weight loss. Stand-alone digital health treatments may be a viable option for those looking for a lower intensity approach. TRIAL REGISTRATION:ClinicalTrials.gov NCT03254953; https://clinicaltrials.gov/ct2/show/NCT03254953 (Archived by WebCite at http://www.webcitation.org/72PyQrFjn).

Project description:BACKGROUND:Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA)-related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA. METHODS:The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programs, self-management, and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3?months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1?month and 3-month follow-up. DISCUSSION:This study will evaluate the effectiveness of a tele-rehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient's status and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care. TRIAL REGISTRATION:ClinicalTrials.gov NCT04263974 . Registered on 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

Project description:BackgroundSurgical site infections (SSI) represent a significant public health problem as the most common nosocomial infection and a leading cause of unplanned hospital readmissions among surgical patients. Many develop following hospital discharge and often go unrecognized by patients. Telemedicine offers the opportunity to leverage the mobile technology to remotely monitor wound recovery in the transitional period between hospital discharge and routine clinic follow-up. However, many existing telemedicine platforms are episodic, replacing routine follow-up, rather than equipped for continued monitoring; they include only low-risk patient populations and those who already have access to and comfort with the necessary technology; and transmit no visual information.ObjectiveDrawing upon the Coleman model for care transitions and the Proctor model for implementation, we propose a protocol of postoperative wound monitoring using smartphone digital images. In this study, we will establish the feasibility of such a program, both for patients and for the clinical care team.MethodsWe will recruit 40 patients or patient/caregiver pairs from our inpatient vascular surgery service. Eligible patients will be English-speaking, 18 years of age or older, and have an incision at least 3 cm in length. Participants will receive a training session, during which they will learn to use the device and the wound monitoring smartphone app. Following hospital discharge, they will submit digital images of their wound and responses to a survey about their recovery for 14 days. Experienced health care providers on the vascular surgery inpatient service will review transmitted data daily and contact patients for any concerning findings.ResultsPrimary outcomes will include participant adherence to the protocol, time required for providers to review submissions, time from submission to provider review, and participant satisfaction. Secondary outcomes will include SSI detection and hospital readmission.ConclusionsHealth systems are increasingly dedicating efforts to transitional care improvement programs. This feasibility trial will confirm whether patients and their caregivers can learn to use a postdischarge wound monitoring smartphone app and will assess patient and provider satisfaction. This protocol will provide preliminary evidence for a shift in the delivery of postdischarge care in a patient-centered and cost-effective manner.Trial registrationClinicaltrials.gov NCT02735525; https://clinicaltrials.gov/ct2/show/NCT02735525 (Archived by WebCite at http://www.webcitation.org/6oIvN4Mab).

Project description:BackgroundTreatment and monitoring decisions in people with multiple sclerosis (MS) are based commonly on clinician-reported outcomes. These reflect physical and radiological disease activity and are the most relevant endpoints in clinical trials. Over the past few years, the number of studies evaluating so-called patient-reported outcomes (PROs) has been increasing. PROs are reports from patients concerning their own health perception. They are typically obtained by means of questionnaires and aim to quantify symptoms such as fatigue, depression, and sexual dysfunction. The emergence of PROs has made a tremendous contribution to understanding the individual impact of disease in people with MS and their health-related quality of life. However, the assessment of PROs consumes resources, including time and personnel. Thus, useful ways to conveniently introduce PROs into clinical practice are needed.ObjectiveWe aim to provide a rationale and pilot study protocol for a mobile health (mHealth) solution named "haMSter" that allows for remote monitoring of PROs in people with MS.MethodsThe core function of haMSter is to provide three scientifically validated PRO questionnaires relevant to MS for patients to fill out at home once a month. Thereby, longitudinal and remote documentation of PROs is enabled. A scoring algorithm graphically plots PRO scores over time and makes them available at the next visit.ResultsThe pilot study is currently ongoing and will evaluate adherence to this mHealth solution in 50 patients over a period of 6 months. Results from the haMSter pilot study are expected in 2021.ConclusionshaMSter is a novel mHealth-based solution for modern PRO research, which may constitute the first step in achieving the ability to integrate PROs in clinical practice. This allows for a more problem-oriented approach in monitoring visits, which addresses patient needs and ultimately saves time.Trial registrationClinicalTrials.gov NCT04555863; https://clinicaltrials.gov/ct2/show/NCT04555863.International registered report identifier (irrid)DERR1-10.2196/25011.

Dataset Information

A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial.

Publications

A Smartphone App for Self-Monitoring of Rheumatoid Arthritis Disease Activity to Assist Patient-Initiated Care: Protocol for a Randomized Controlled Trial.

Similar Datasets

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