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Depósito de investigación de la Universidad de Sevilla https://idus.us.es/ Esta es la versión aceptada del artículo publicado en: This is a accepted manuscript of a paper published in: Journal of advanced nursing (2022): May 2022 DOI: https://doi.org/10.1111/jan.15151 Copyright: © 2022 John Wiley & Sons Ltd. El acceso a la versión publicada del artículo puede requerir la suscripción de la revista. Access to the published version may require subscription. “This is the peer reviewed version of the following article: Sánchez-Gutiérrez C, Gil-García E, Rivera-Sequeiros A, López-Millán JM. Effectiveness of telemedicine psychoeducational interventions for adults with non-oncological chronic disease: A systematic review. J Adv Nurs. 2022 May;78(5):1267-1280, which has been published in final at form https://doi.org/10.1111/jan.15151 This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. This article may not be enhanced, enriched or otherwise transformed into a derivative work, without express permission from Wiley or by statutory rights under applicable legislation. Copyright notices must not be removed, obscured or modified. The article must be linked to Wiley’s version of record on Wiley Online Library and any embedding, framing or otherwise making available the article or pages thereof by third parties from platforms, services and websites other than Wiley Online Library must be prohibited."
Review Copy Effectiveness of mHealth and telemedicine psychoeducational interventions for adults with nononcological chronic disease: A systematic review. Journal: Journal of Advanced Nursing Manuscript ID JAN-2021-1250 Manuscript Type: Review Keywords: Chronic Illness, Health Education, Clinical Effectiveness, Patient Participation, Psychosocial Nursing, Self-care, Telenursing, Technology, Empowerment Category: Nursing Journal of Advanced Nursing
Review Copy 1 Effectiveness of mHealth and telemedicine psychoeducational interventions for adults with non-oncological chronic disease: A systematic review. ABSTRACT Aim: To provide an overview of the effectiveness of mHealth and telemedicine psychoeducational interventions for adult patients on clinical control of non-oncological chronic diseases in comparison with another therapeutic option or no treatment. Design: Systematic review following PRISMA 2020 guidelines. Data Sources: Web Of Science, Scopus, CINAHL, PubMed/MEDLINE, PsycINFO y Cochrane Library were systematically searched for studies published between January 2011-August 2020. Review methods: Studies were included if they were randomized clinical trials comparing the effectiveness of the telemedicine or mHealth psychoeducational interventions (alone or in combination with others) with other therapeutic modalities, a placebo, or no intervention or treatment; were published in English, Portuguese and Spanish; and their full text were available. Non-scientific articles, qualitative research, letters to the editor, systematic reviews, meta-analysis, quasi-experimental studies, descriptive studies, case studies, and clinical trial protocols were excluded. Two independent reviewers assessed the studies attending inclusion criteria and PEdro quality scale. A third arbiter was available in case of discrepancies. Results: We screened 656 articles. Fifteen studies met the inclusion and quality criteria. The included studies were related to smoking, chronic pain, obesity, and mental diseases evaluated by validated mental health measures. Most interventions were based on cognitive-behavioral theory. The heterogeneity in medical diagnoses, outcomes, intervention content, and structure precluded meta-analysis. The majority of included Page 1 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 2 studies (11/15, 73.3%) reported significant changes in measured health post-treatment outcomes, with small to large effect sizes. Conclusions: mHealth and telemedicine psychoeducational interventions are promising strategies for the self-care of adults with chronic diseases. These interventions stand as safe and adequate forms of self-management in the epidemiological COVID-19 context. Impact: The results reinforce telemedicine and mHealth by having effects on clinical control similar to those of the face-to-face modality and can be carried out from a safe environment for patients and at a lower cost for the Health System. Keywords: clinical effectiveness; chronic illness; empowerment; health education; patient participation; psychosocial nursing; self-care; technology; telenursing. Page 2 of 31Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 3 1. INTRODUCTION Engel (Engel, 1977) postulated the need for a holistic medical model for diagnostic and therapeutic approaches to different diseases. In this comprehensive vision, the active participation of patients is decisive for the control of their health. Psychoeducational interventions (PI) are non-pharmacological briefing given by health professionals to instruct patients and caregivers in knowledge and skills for the development of positive adaptive behaviors. They have demonstrated a positive health impact in different chronic pathologies (Conejo-Cerón et al., 2020; Conversano et al., 2019; Davis et al., 2019). We are experiencing an increase in life expectancy, an aging population and, consequently, an increase in chronic diseases. Psychoeducation should be considered as a part of comprehensive care in the face of this prospect of expansion of chronic pathologies. mHealth encompasses practices aimed at improving collective health by mobile devices and interactive telemedicine offers real-time communication between professionals and patients in writing or by video call. Both fulfill the ideal conditions for the system, since they are safe, economical and offer universal access to the patient (Corry et al., 2019; Kvedar et al., 2014). 2. BACKGROUND Telemedicine and mHealth applications for health promotion and control of different diseases have been studied (Mikolasek et al., 2018; Oksman et al., 2017; Rathbone & Prescott, 2017). When we focus our perspective on PI, few studies are provided by internet or telemedicine and most of them are restricted to the field of mental illnesses. Page 3 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 4 As a preliminary step in this review, we conducted a search for systematic reviews and meta-analyses using the same search strategy. The only review that met the inclusion criteria (Rathbone & Prescott, 2017) showed promising efficacy of the use of mobile apps and SMS text messages in different diseases, although it was not specified whether the interventions were psychoeducational or not. The few results found were promising and fundamental for the justification of this review focused on PI by mHealth or telemedicine. Given the changes due to the COVID-19 pandemic that promote remote care as far as possible, the higher prevalence of chronic diseases, the increasingly numerous populations to attend to and the benefits reported by PI, we propose this review. 3. THE REVIEW 3.1. Aims In response to PICO (Population, Intervention, Comparator, Outcome) questions, our objective was to evaluate the effectiveness of non-face-to-face PI by mHealth or telemedicine by video calls, applications on mobile devices, text messages and websites aimed at adult patients with respect to clinical control of non-oncological chronic diseases compared to another therapeutic option or no treatment. 3.2. Design The systematic review protocol was registered at PROSPERO (the registration number and URL are kept hidden to ensure blinding). 3.3. Search Method We developed a systematic peer review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) (Moher et al., 2015). The following databases were used for this: Web of Science, Scopus, CINAHL, PubMed / MEDLINE, PsycINFO and Cochrane Library from January 1st, 2011 to July 31st, 2020. Page 4 of 31Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 5 The search strategy contained a combination of keywords and Medical Subject Head (MESH). The final search strategy used was: "(effectiveness) AND (intervention OR workshop) AND (psychoeducation*) AND (telemedicine OR electronic health OR mobile health)". 3.4. Inclusion and exclusion criteria Full articles were reviewed when titles and abstracts met the inclusion criteria: 1) outpatients over 18 years of age with chronic non-oncological disease; 2) randomized clinical trials (RCT) comparing the effects of the PIs by telemedicine or mHealth (alone or in combination with others) with other therapeutic modalities, a placebo, or no intervention or treatment; 3) effectiveness of PI in the clinical control as a result; 4) were published in English, Portuguese and Spanish; 5) full text available. Studies were excluded when: 1) they were non-scientific articles, qualitative research, letters to the editor, systematic reviews, meta-analysis, quasi-experimental studies, descriptive studies, case studies, and clinical trial protocols; or 2) they were focused on the harmful effects of mobile phones or the Internet. 3.5. Search Outcomes All references were exported and managed with Mendeley Reference Manager. Of the articles retrieved in the search, two independent researchers reviewed titles and abstracts to determine inclusion. These same researchers then reviewed the full text of the included publications. If the study did not meet the inclusion criteria, it was excluded from further analysis. The initial search strategy identified 656 studies and were reduced to 537 after removing duplicates. Of these, after reviewing the title and abstract, 34 articles were selected to assess methodological quality using the PEDro scale (Table 1) and 19 articles were discarded after this analysis (Figure 1). 3.6. Quality appraisal Page 5 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 6 The methodological quality and internal validity of the remaining articles were assessed using the PEDro scale (0 to 10 proportional to quality) (Cashin and McAuley, 2020) by the independent reviewers. The PEDro scale is a rating scale for assessing the methodological quality of clinical trials. Initially, the PEDro scale was designed to rate the quality of clinical trials indexed in the Physiotherapy Evidence Database (PEDro), but it is now increasingly used to rate clinical trials included in systematic reviews of research in physiotherapy, health and medicine. In total, the PEDro scale consists of 11 items covering external validity (item 1), internal validity (items 2 to 9) and statistical reporting (items 10 to 11). Items with a PEDro scale value below 6 or with one or more exclusion criteria were discarded from the analysis. During the inclusion process, in case of discrepancies between the reviewers, a collaborative evaluation was carried out by a third arbiter. 3.7. Data Synthesis Data were extracted from all full-text reports by two independent reviewers. First, the information obtained was extracted to organize the data and prepare it for analysis: year of publication, study location, sample size and characteristics, dropout rate, measurement instruments, and health outcomes. Due to the variety of designs and results of the included studies and the different measures used, a meta-analysis of the findings was not possible. Second, descriptive statistics were used to obtain the sum, mean, standard deviation, percentage, and sample characteristics of the included studies. All data were analyzed using the Statistical Package for Social Sciences (SPSS) 26.0. The findings are presented in the "Results" section in a table form with a synthesis based on the statistically significant results (p< 0.05) on the efficacy of IPs in the management of the chronic disease studied. The data extraction and synthesis process were completed by Page 6 of 31Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 7 two reviewers independently and any case of disagreement was resolved by consensus with a third referee. 3.8. Data Abstraction The characteristics of the 15 articles that were finally included in the review have been presented, specifying the author, year of publication, country, sample (number, gender, dropout rate), intervention performed, outcome variables, the timing of measurement and health outcomes (Table 2). 4. RESULTS 4.1. Characteristics of the participating subjects The total number of subjects included in the sample of the selected studies was 2963 (67% women). The mean age of the participants was 41.91(SD 9.38) years. The predominant conditions were "married" or "living with a partner" (46.6%), active employment (40%), and a level of secondary education or higher (60%). Regarding ethnicity, economic level and area of residence (rural or urban), there is no uniform information available in the different studies to characterize the total sample. The studies reviewed addressed chronic smoking (McClure et al., 2016), chronic pain in upper limbs (Westenberg et al., 2018), obesity and depressive syndrome after bariatric surgery (Wild et al., 2015) and mental illnesses (Aardoom et al., 2016; Arjadi et al., 2018; Beiwinkel et al., 2017; Depp et al., 2019; Gliddon et al., 2019; Glozier et al., 2019; Lovell et al., 2017; McCusker et al., 2016; Nobis et al., 2015; Schmidt et al., 2014; Schuster et al., 2017; Zanarini et al., 2018) (Table 3). 4.2. Study characteristics All the studies were randomized clinical trials (RCTs), two of them multicenter (Gliddon et al., 2019; Lovell et al., 2017). In their design, the majority established two Page 7 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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Review Copy 21 Randomized Clinical Trials. In JAMA Psychiatry (Vol. 77, Issue 10, pp. 1031– 1043). American Medical Association. https://doi.org/10.1001/jamapsychiatry.2020.0431 Soto-Pérez, F. (2016). Cybertherapies: treatments mediated by computer and other technologies. In Distance Continuing Education General Council of Psychology of Spain FOCAD (Vol. 29, pp. 1–29). van Ballegooijen, W., Cuijpers, P., van Straten, A., Karyotaki, E., Andersson, G., Smit, J. H., & Riper, H. (2014). Adherence to internet-based and face-to-face cognitive behavioural therapy for depression: A meta-analysis. PLoS ONE, 9(7). https://doi.org/10.1371/journal.pone.0100674 Westenberg, R. F., Zale, E. L., Heinhuis, T. J., Ozkan, S., Nazzal, A., Lee, S.-G. S. G., Chen, N. C., & Vranceanu, A. M. A.-M. (2018). Does a brief mindfulness exercise improve outcomes in upper extremity patients? A randomized controlled trial. Clinical Orthopaedics and Related Research, 476(4), 790–798. https://doi.org/10.1007/s11999.0000000000000086 Wild, B., Hünnemeyer, K., Sauer, H., Hain, B., Mack, I., Schellberg, D., Müller-Stich, B. P., Weiner, R., Meile, T., Rudofsky, G., Königsrainer, A., Zipfel, S., Herzog, W., & Teufel, M. (2015). A 1-year videoconferencing-based psychoeducational group intervention following bariatric surgery: results of a randomized controlled study. Surgery for Obesity and Related Diseases: Official Journal of the American Society for Bariatric Surgery, 11(6), 1349–1360. https://doi.org/10.1016/j.soard.2015.05.018 Zanarini, M. C., Conkey, L. C., Temes, C. M., & Fitzmaurice, G. M. (2018). Randomized controlled trial of web-based psychoeducation for women with Page 21 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy 22 borderline personality disorder. The Journal of Clinical Psychiatry, 79(3), 52–59. https://doi.org/10.4088/JCP.16m11153 Page 22 of 31Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy FIGURE 1: FLOWCHART FOR ARTICLE SELECTION Number of studies identified through database searches (n =656) Screening Identification Inclusion Suitability Number of studies screened by title and abstract (n = 531) Number of studies excluded (n = 497) Number of full-text articles evaluated for eligibility (n = 34) Number of full-text articles excluded (n = 19) 1 population under 16 years of age 1 for face-to-face intervention 1 due to data replication with another RCT 16 by PEDro scale <6 Number of included studies (n =15) CINAHL (n = 25) PSYCINFO (n = 40) SCOPUS (n = 67) WOS (n =43) PUBMED (n =337) COCHRANE (n = 144) Number of studies after eliminating duplicate citations (n = 531) Identification Page 23 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy PRISMA 2020 Checklist Section and Topic Item # Checklist item: Effectiveness of mHealth and telemedicine psychoeducational interventions for adults with nononcological chronic disease: a systematic review. Location where item is reported (page) heterogeneity, and software package(s) used. 13e Describe any methods used to explore possible causes of heterogeneity among study results (e.g. subgroup analysis, meta-regression). 6 13f Describe any sensitivity analyses conducted to assess robustness of the synthesized results. - Reporting bias assessment 14 Describe any methods used to assess risk of bias due to missing results in a synthesis (arising from reporting biases). 5, table 2 Certainty assessment 15 Describe any methods used to assess certainty (or confidence) in the body of evidence for an outcome. - RESULTS 16a Describe the results of the search and selection process, from the number of records identified in the search to the number of studies included in the review, ideally using a flow diagram. 5, figure 1 Study selection 16b Cite studies that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded. 5, figure 1 Study characteristics 17 Cite each included study and present its characteristics. 7-8 Risk of bias in studies 18 Present assessments of risk of bias for each included study. 6, table 1 Results of individual studies 19 For all outcomes, present, for each study: (a) summary statistics for each group (where appropriate) and (b) an effect estimate and its precision (e.g. confidence/credible interval), ideally using structured tables or plots. 6, table 2 20a For each synthesis, briefly summarise the characteristics and risk of bias among contributing studies. 6, table 1 20b Present results of all statistical syntheses conducted. If meta-analysis was done, present for each the summary estimate and its precision (e.g. confidence/credible interval) and measures of statistical heterogeneity. If comparing groups, describe the direction of the effect. 6, table 2 20c Present results of all investigations of possible causes of heterogeneity among study results. 6 Results of syntheses 20d Present results of all sensitivity analyses conducted to assess the robustness of the synthesized results. Table 2 Reporting biases 21 Present assessments of risk of bias due to missing results (arising from reporting biases) for each synthesis assessed. 6-8 Certainty of evidence 22 Present assessments of certainty (or confidence) in the body of evidence for each outcome assessed. 6 DISCUSSION 23a Provide a general interpretation of the results in the context of other evidence. 9-12 23b Discuss any limitations of the evidence included in the review. 13 23c Discuss any limitations of the review processes used. 13 Discussion 23d Discuss implications of the results for practice, policy, and future research. 13 Page 30 of 31Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
Review Copy PRISMA 2020 Checklist Section and Topic Item # Checklist item: Effectiveness of mHealth and telemedicine psychoeducational interventions for adults with nononcological chronic disease: a systematic review. Location where item is reported (page) OTHER INFORMATION 24a Provide registration information for the review, including register name and registration number, or state that the review was not registered. 4 24b Indicate where the review protocol can be accessed, or state that a protocol was not prepared. 4 Registration and protocol 24c Describe and explain any amendments to information provided at registration or in the protocol. NA Support 25 Describe sources of financial or non-financial support for the review, and the role of the funders or sponsors in the review. 14 Competing interests 26 Declare any competing interests of review authors. 14 Availability of data, code and other materials 27 Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review. 4 From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. doi: 10.1136/bmj.n71 For more information, visit: http://www.prisma-statement.org/ Page 31 of 31 Journal of Advanced Nursing 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60