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Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

ABSTRACT: BACKGROUND:The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. OBJECTIVE:The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. METHODS:A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). RESULTS:Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. CONCLUSIONS:This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC).

SUBMITTER: Seto E

PROVIDER: S-EPMC5717446 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

Seto Emily E Ware Patrick P Logan Alexander G AG Cafazzo Joseph A JA Chapman Kenneth R KR Segal Phillip P Ross Heather J HJ

JMIR research protocols 20171121 11

<h4>Background</h4>The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chroni ...[more]

PMID: 29162557

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Project description:ObjectivesThe Self-Management Analysis in Chronic Conditions (SMACC) checklist was developed as a guidance tool to support the development, comparison and evaluation of self-management support programmes for persons with a chronic condition. The checklist was based on a previously performed concept analysis of self-management. The aim of this study was to validate its content using an international Delphi study and to deliver a final version.DesignA two-round Delphi study was conducted between October 2022 and January 2023. Using the researchers' networks, professionals with research or clinical expertise in self-management support and chronic conditions were recruited via online purposive snowball sampling. Participants were asked to score each item of the checklist (16 items total) on 3 content validity indicators: (1) clarity and comprehensibility, (2) relevance and importance and (3) degree of alignment with the overall goal of the checklist to promote adequate and comprehensive self-management support programmes. A consensus threshold of 75% agreement was used. The participants were also asked general questions about the checklist as a whole and were asked to provide feedback considering its refinement.ResultsFifty-four professionals with an average 14.5 years of experience participated in round 1, 48 with an average 12.5 years of experience participated in round 2. The majority of professionals were from Western Europe. For the majority of items consensus was reached after round 1. In round 2, 3 of the 4 remaining items reached consensus, 1 last item was retained based on highly recurring feedback.ConclusionsThe SMACC checklist was considered a valid and comprehensive tool to aid the development, evaluation and comparison of self-management support programmes. It was acknowledged as a useful instrument to supplement existing frameworks and was seen as feasible to implement in both research and clinical settings. Further validation in the field, with input from patients and peer experts, will be valuable.

Project description:BackgroundLow back pain (LBP) is a leading cause of disability worldwide. Most patients with LBP encountered in primary care settings have nonspecific LBP, that is, pain with an unknown pathoanatomical cause. Self-management in the form of physical activity and strength and flexibility exercises along with patient education constitute the core components of the management of nonspecific LBP. However, the adherence to a self-management program is challenging for most patients, especially without feedback and reinforcement. Here we outline a protocol for the design and implementation of a decision support system (DSS), selfBACK, to be used by patients themselves to promote self-management of LBP.ObjectiveThe main objective of the selfBACK project is to improve self-management of nonspecific LBP to prevent chronicity, recurrence and pain-related disability. This is achieved by utilizing computer technology to develop personalized self-management plans based on individual patient data.MethodsThe decision support is conveyed to patients via a mobile phone app in the form of advice for self-management. Case-based reasoning (CBR), a technology that utilizes knowledge about previous cases along with data about the current patient case, is used to tailor the advice to the current patient, enabling a patient-centered intervention based on what has and has not been successful in previous patient cases. The data source for the CBR system comprises initial patient data collected by a Web-based questionnaire, weekly patient reports (eg, symptom progression), and a physical activity-detecting wristband. The effectiveness of the selfBACK DSS will be evaluated in a multinational, randomized controlled trial (RCT), targeting care-seeking patients with nonspecific LBP. A process evaluation will be carried out as an integral part of the RCT to document the implementation and patient experiences with selfBACK.ResultsThe selfBACK project was launched in January 2016 and will run until the end of 2020. The final version of the selfBACK DSS will be completed in 2018. The RCT will commence in February 2019 with pain-related disability at 3 months as the primary outcome. The trial results will be reported according to the CONSORT statement and the extended CONSORT-EHEALTH checklist. Exploitation of the results will be ongoing throughout the project period based on a business plan developed by the selfBACK consortium. Tailored digital support has been proposed as a promising approach to improve self-management of chronic disease. However, tailoring self-management advice according to the needs, motivation, symptoms, and progress of individual patients is a challenging task. Here we outline a protocol for the design and implementation of a stand-alone DSS based on the CBR technology with the potential to improve self-management of nonspecific LBP.ConclusionsThe selfBACK project will provide learning regarding the implementation and effectiveness of an app-based DSS for patients with nonspecific LBP.Registered report identifierRR1-10.2196/9379.

Project description:BackgroundHypertension is a widespread chronic disease, and its effective treatment requires self-management by patients. Health-related apps provide an effective way of supporting hypertension self-management. However, the increasing range and variety of hypertension apps available on the market, owing to the global growth in apps, creates the need for patients and health care professionals to be informed about the effectiveness of these apps and the levels of privacy and security that they provide.ObjectiveThis study aimed to describe and assess all available apps supporting hypertension self-management in the most popular app stores and investigate their functionalities.MethodsIn January 2018, the UK Apple and Google Play stores were scanned for all free and paid apps supporting hypertension self-management. Apps were included if they were in English, had functionality supporting hypertension self-management, and targeted adult users with hypertension. The included apps were downloaded and their functionalities were investigated. Behavior change techniques (BCTs) linked with the theoretical domain framework (TDF) underpinning potentially effective apps were independently coded by two reviewers. The data privacy and security of the apps were also independently assessed.ResultsA total of 186 hypertension apps that met the inclusion criteria were included in this review. The majority of these apps had only one functionality (n=108), while the remainder offered different combinations of functionalities. A small number of apps had comprehensive functionalities (n=30) that are likely to be more effective in supporting hypertension self-management. Most apps lacked a clear theoretical basis, and 24 BCTs identified in these 30 apps were mapped to 10 TDF mechanisms of actions. On an average, 18.4 BCTs were mapped to 6 TDF mechanisms of actions that may support hypertension self-management behaviors. There was a concerning absence of evidence related to the effectiveness and usability of all 186 apps, and involvement of health care professionals in the app development process was minimal. Most apps did not meet the current standards of data security and privacy.ConclusionsDespite the widespread accessibility and availability of smartphone apps with a range of combinations of functionalities that can support the self-management of hypertension, only a small number of apps are likely to be effective. Many apps lack security measures as well as a clear theoretical basis and do not provide any evidence concerning their effectiveness and usability. This raises a serious issue, as health professionals and those with hypertension have insufficient information to make decisions on which apps are safe and effective.

Project description:BackgroundTelemonitoring for the remote patient self-management of chronic conditions can be a cost-effective method for delivering care in chronic disease; nonetheless, its implementation in clinical practice remains low. The aim of this meta-synthesis is to explore barriers and facilitators associated with the use of remote patient monitoring of chronic disease, drawing on qualitative research, and assessing participant interactions with this technology.MethodA meta-synthesis of qualitative studies was performed. MEDLINE, SCOPUS and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from database date of inception to 5 February 2021. The Critical Appraisal Skills Programme (CASP) was used to critically appraise each study. Thematic synthesis was performed to identify user (patients, carers and healthcare professionals) perspectives and experiences of patient remote monitoring of chronic disease (Type 2 diabetes mellitus, chronic obstructive pulmonary disease, and cardiovascular disease).ResultsSearches returned 10,401 studies and following independent screening by two reviewers, nine studies were included in this meta-synthesis. Data were synthesised and categorised into four key themes: (1) Improved care; (2) Communication; (3) Technology feasibility & acceptability; and (4) Intervention concerns. Most patients using patient remote devices felt motivated in managing their own lifestyles and felt reassured by the close monitoring and increased communication. Barriers identified involved generational differences and difficulties with the technology used.ConclusionMost studies showed a positive attitude to telemonitoring, with patients preferring the convenience of telemonitoring in comparison to attending regular clinics. Further research is required to assess the most effective technology for chronic disease management, how to maintain long-term patient adherence, and identify effective approaches to address generational variation in telemonitoring up-take.

Project description:BackgroundInternational guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions.ObjectiveThe aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability.MethodsThe first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of >2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study.ResultsA behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory.ConclusionsWe describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management.

Project description:BackgroundDespite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population.ObjectiveThis randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care.MethodsA pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences.ResultsA total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF.ConclusionsWe recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care.Trial registrationClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852.International registered report identifier (irrid)RR2-10.2196/resprot.8367.

Project description:The emergence of mobile technology offers new opportunities to improve clinical guideline adherence in resource-limited settings. We conducted a clinical pilot study in rural Bangladesh to evaluate the impact of a smartphone adaptation of the World Health Organization (WHO) diarrheal disease management guidelines, including a modality for age-based weight estimation. Software development was guided by end-user input and evaluated in a resource-limited district and sub-district hospital during the fall 2015 cholera season; both hospitals lacked scales which necessitated weight estimation. The study consisted of a 6 week pre-intervention and 6 week intervention period with a 10-day post-discharge follow-up. Standard of care was maintained throughout the study with the exception that admitting clinicians used the tool during the intervention. Inclusion criteria were patients two months of age and older with uncomplicated diarrheal disease. The primary outcome was adherence to guidelines for prescriptions of intravenous (IV) fluids, antibiotics and zinc. A total of 841 patients were enrolled (325 pre-intervention; 516 intervention). During the intervention, the proportion of prescriptions for IV fluids decreased at the district and sub-district hospitals (both p < 0.001) with risk ratios (RRs) of 0.5 and 0.2, respectively. However, when IV fluids were prescribed, the volume better adhered to recommendations. The proportion of prescriptions for the recommended antibiotic azithromycin increased (p < 0.001 district; p = 0.035 sub-district) with RRs of 6.9 (district) and 1.6 (sub-district) while prescriptions for other antibiotics decreased; zinc adherence increased. Limitations included an absence of a concurrent control group and no independent dehydration assessment during the pre-intervention. Despite limitations, opportunities were identified to improve clinical care, including better assessment, weight estimation, and fluid/ antibiotic selection. These findings demonstrate that a smartphone-based tool can improve guideline adherence. This study should serve as a catalyst for a randomized controlled trial to expand on the findings and address limitations.

Dataset Information

Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

Publications

Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

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