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A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.

ABSTRACT: 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.

SUBMITTER: Rodriguez-Sanchez-Laulhe P

PROVIDER: S-EPMC7488084 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.

Rodríguez-Sánchez-Laulhé Pablo P Luque-Romero Luis Gabriel LG Blanquero Jesús J Suero-Pineda Alejandro A Biscarri-Carbonero Ángela Á Barrero-García Francisco José FJ Heredia-Rizo Alberto Marcos AM

Trials 20200910 1

<h4>Background</h4>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.<h4>Methods</h4>The project is a prospective, longitudinal, superiorit ...[more]

PMID: 32912305

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Project description:BackgroundRheumatoid arthritis flares have a profound effect on patients, causing pain and disability. However, flares often occur between regularly scheduled health care provider visits and are, therefore, difficult to monitor and manage. We sought to develop a mobile phone app combined with a population management system to help track RA flares between visits.ObjectiveThe objective of this study is to implement the mobile app plus the population management system to monitor rheumatoid arthritis disease activity between scheduled health care provider visits over a period of 6 months.MethodsThis is a randomized controlled trial that lasts for 6 months for each participant. We aim to recruit 190 patients, randomized 50:50 to the intervention group versus the control group. The intervention group will be assigned the mobile app and be prompted to answer daily questionnaires sent to their mobile devices. Both groups will be assigned a population manager, who will communicate with the participants via telephone at 6 weeks and 18 weeks. The population manager will also communicate with the participants in the intervention group if their responses indicate a sustained increase in rheumatoid arthritis disease activity. To assess patient satisfaction, the primary outcomes will be scores on the Treatment Satisfaction Questionnaire for Medication as well as the Perceived Efficacy in Patient-Physician Interactions questionnaire at 6 months. To determine the effect of the mobile app on rheumatoid arthritis disease activity, the primary outcome will be the Clinical Disease Activity Index at 6 months.ResultsThe trial started in November 2016, and an estimated 2.5 years will be necessary to complete the study. Study results are expected to be published by the end of 2019.ConclusionsThe completion of this study will provide important data regarding the following: (1) the assessment of validated outcome measures to assess rheumatoid arthritis disease activity with a mobile app between routinely scheduled health care provider visits, (2) patient engagement in monitoring their condition, and (3) communication between patients and health care providers through the population management system.Trial registrationClinicalTrials.gov NCT02822521, http://clinicaltrials.gov/ct2/show/NCT02822521 (Archived by WebCite at http://www.webcitation.org/6xed3kGPd).

Project description:BackgroundRheumatoid arthritis (RA) is a prevalent autoimmune disease that usually involves problems of the hand or wrist. Current evidence recommends a multimodal therapy including exercise, self-management, and educational strategies. To date, the efficacy of this approach, as delivered using a smartphone app, has been scarcely investigated.ObjectiveThis study aims to assess the short- and medium-term efficacy of a digital app (CareHand) that includes a tailored home exercise program, together with educational and self-management recommendations, compared with usual care, for people with RA of the hands.MethodsA single-blinded randomized controlled trial was conducted between March 2020 and February 2021, including 36 participants with RA of the hands (women: 22/36, 61%) from 2 community health care centers. Participants were allocated to use the CareHand app, consisting of tailored exercise programs, and self-management and monitoring tools or to a control group that received a written home exercise routine and recommendations, as per the usual protocol provided at primary care settings. Both interventions lasted for 3 months (4 times a week). The primary outcome was hand function, assessed using the Michigan Hand Outcome Questionnaire (MHQ). Secondary measures included pain and stiffness intensity (visual analog scale), grip strength (dynamometer), pinch strength (pinch gauge), and upper limb function (shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire). All measures were collected at baseline and at a 3-month follow-up. Furthermore, the MHQ and self-reported stiffness were assessed 6 months after baseline, whereas pain intensity and scores on the shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire were collected at the 1-, 3-, and 6-month follow-ups.ResultsIn total, 30 individuals, corresponding to 58 hands (CareHand group: 26/58, 45%; control group: 32/58, 55%), were included in the analysis; 53% (19/36) of the participants received disease-modifying antirheumatic drug treatment. The ANOVA demonstrated a significant time×group effect for the total score of the MHQ (F1.62,85.67=9.163; P<.001; η2=0.15) and for several of its subscales: overall hand function, work performance, pain, and satisfaction (all P<.05), with mean differences between groups for the total score of 16.86 points (95% CI 8.70-25.03) at 3 months and 17.21 points (95% CI 4.78-29.63) at 6 months. No time×group interaction was observed for the secondary measures (all P>.05).ConclusionsAdults with RA of the hands who used the CareHand app reported better results in the short and medium term for overall hand function, work performance, pain, and satisfaction, compared with usual care. The findings of this study suggest that the CareHand app is a promising tool for delivering exercise therapy and self-management recommendations to this population. Results must be interpreted with caution because of the lack of efficacy of the secondary outcomes.Trial registrationClinicalTrials.gov NCT04263974; https://clinicaltrials.gov/ct2/show/NCT04263974.International registered report identifier (irrid)RR2-10.1186/s13063-020-04713-4.

Project description:IntroductionMobile apps are considered intelligent tools useful in various areas of public health. The social dimension of breast cancer and the current epidemic situation require tools that may increase knowledge and improve the skills in the field of breast self-examination. The study aims to assess the use of personalized education based on algorithms with conditions in the mobile medical app for breast self-examination.Materials and methodsIn total, 500 women from the Podkarpackie Province were enrolled in the study, which was a representative group for the inhabitants of this province. The subjects were randomly divided into two groups (group I: the study group including 250 people; group II: the controls of 250 people). The study group was subjected to intervention, which was personalized education on breast cancer. The method was a proprietary mobile medical app based on algorithms with conditions. The study was carried out from March 2018 to February 2019.ResultsThe majority of women, 77.8% (N = 389), were under 30 years of age. Only a small amount of the breast area was marked in the tactile test in both groups. In the study group, the average number of selected points was 14.86 (7.43% of the area to be examined), while in the control group it amounted to 9.14 (4.57%). The area most commonly examined in Test I in both groups was the central area of the mammary gland with the nipple. After the intervention in Test II, women from the study group marked a significantly greater area in the tactile test than women from the control group (χ2 = 99.733; df = 6; p < 0.0001). The mean result in the study group was 22.10, while in the control group it amounted to 9.10. It was found that the breast area marked in both tests depended solely on the women's knowledge about breast cancer (p < 0.001). It was also found that the higher the risk of developing breast cancer, the more points in Test I were indicated by the women in the tactile test (p = 0.0122).ConclusionsEducational mobile medical apps for breast cancer prevention may help to deal with breast cancer, which is an important public health issue. It is also important to broaden the possibilities of medical apps for breast self-examination with elements verifying the skills of the three-stage compression of the examined breast.

Project description:BackgroundMultiple sclerosis (MS) is one of the most common neurological disorders worldwide, and self-management is considered an essential dimension in its control. This study aimed to develop an evidence-based mobile application for MS self-management and evaluate it.MethodsThis study was undertaken in three phases: content preparation, design, and evaluation. In the content preparation phase, the researchers extracted MS self-management needs based on related guidelines and guides, existing apps on the self-management of MS, and the field experts' views and confirmation. The design phase was conducted in five steps: defining app functionalities, depicting the wireframe, preparing the media, coding the app, and testing the app's performance. The app was developed using the Android Studio environment and Java programming language for the Android operating system. The performance of the developed app was tested separately in several turns, and existing defects were corrected in each turn. Finally, after using the app for three weeks, the app was evaluated for its short-term impact on MS management and user-friendliness using a researcher-constructed questionnaire from participants' (N = 20) perspectives.ResultsThe IDoThis app is an offline app for people with MS that includes five main modules: three modules for training or informing users about different aspects of MS, one module for monitoring the user's MS condition, and a reporting module. In the initial evaluation of the app, 75% (n = 15) of participants mentioned that using this app improved MS self-management status at intermediate and higher levels, but 25% (n = 5) of the participants mentioned that the effect of using the app on the self-management tasks was low or was very low. The majority of users rated the user-friendliness of the app as high. The users found the sections "exercises in MS" and "monitoring of MS status" beneficial to their self-management. Still, the fatigue and sleep management sections are needed to meet users' expectations.ConclusionUsing IDoThis app as a self-management tool for individuals with MS appears feasible, that can meet the need for a free and accessible self-management tool for individuals with MS. Future directions should consider the users' fatigue and sleep management expectations.

Project description:BackgroundThe Strengthening and Stretching for Rheumatoid Arthritis of the Hand (SARAH) program is a tailored, progressive 12-week exercise program for people with hand problems due to rheumatoid arthritis. The program was shown to be clinically and cost-effective in a large clinical trial and is recommended by the UK National Institute for Health and Care Excellence (NICE) guidelines for rheumatoid arthritis in adults.ObjectiveWe have developed an online version of the SARAH program (mySARAH) to make the SARAH program widely accessible to people with rheumatoid arthritis. The purposes of this study were to develop mySARAH and to evaluate and address its usability issues.MethodsWe developed mySARAH using a three-step process and gaining feedback from patient contributors. After initial development, mySARAH was tested in two iterative usability cycles in nine participants using a simplified think-aloud protocol and self-reported questionnaires. We also evaluated if participants executed the SARAH exercises correctly after watching the exercise videos included on the website.ResultsA preliminary version of mySARAH consisting of six sessions over a 12-week period and delivered via text, exercise videos, images, exercise plan form, exercise calendar, and links to additional information on rheumatoid arthritis was developed. Five participants (1 male; 4 females; median age 64 years) and four participants (four females; median age 64.5 years) took part in the first and second usability testing cycles respectively. Usability issues identified from Cycle 1 such as having a navigation tutorial video and individualised feedback on pain levels were addressed prior to Cycle 2. The need for more instructions to complete the mySARAH patient forms was identified in Cycle 2 and was rectified. Self-reports from both cycles indicated that participants found the program useful and easy to use and were confident in performing the SARAH exercises themselves. Eight of the nine participants correctly demonstrated all the exercises.ConclusionsmySARAH is the first online hand exercise intervention for people with rheumatoid arthritis. We actively involved target users in the development and usability evaluation and ensured mySARAH met their needs and preferences.

Project description:BackgroundSelf-regulation theory suggests people learn to influence their own behavior through self-monitoring, goal-setting, feedback, self-reward, and self-instruction, all of which smartphones are now capable of facilitating. Several mobile apps exist to manage asthma; however, little evidence exists about whether these apps employ user-centered design processes that adhere to government usability guidelines for mobile apps.ObjectiveBuilding upon a previous study that documented adolescent preferences for an asthma self-management app, we employed a user-centered approach to assess the usability of a high-fidelity wireframe for an asthma self-management app intended for use by adolescents with persistent asthma.MethodsIndividual interviews were conducted with adolescents (ages 11-18 years) with persistent asthma who owned a smartphone (N=8). Adolescents were asked to evaluate a PDF app wireframe consisting of 76 screen shots displaying app features, including log in and home screen, profile setup, settings and info, self-management features, and graphical displays for charting asthma control and medication. Preferences, comments, and suggestions for each set of screen shots were assessed using the audio-recorded interviews. Two coders reached consensus on adolescent evaluations of the following aspects of app features: (1) usability, (2) behavioral intentions to use, (3) confusing aspects, and (4) suggestions for improvement.ResultsThe app wireframe was generally well received, and several suggestions for improvement were recorded. Suggestions included increased customization of charts and notifications, reminders, and alerts. Participants preferred longitudinal data about asthma control and medication use to be displayed using line graphs. All participants reported that they would find an asthma management app like the one depicted in the wireframe useful for managing their asthma.ConclusionsEarly stage usability tests guided by government usability guidelines (usability.gov) revealed areas for improvement for an asthma self-management app for adolescents. Addressing these areas will be critical to developing an engaging and effective asthma self-management app that is capable of improving adolescent asthma outcomes.

Dataset Information

A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.

Publications

A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol.

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