{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T20:54:13Z","timestamp":1761598453559,"version":"3.37.3"},"reference-count":54,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,8,13]],"date-time":"2022-08-13T00:00:00Z","timestamp":1660348800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,8,13]],"date-time":"2022-08-13T00:00:00Z","timestamp":1660348800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100009945","name":"Merck KGaA","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009945","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Inform Decis Mak"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Caregivers of children undergoing growth hormone treatment often face stress and stigma. In this regard, family-centered approaches are increasingly considered, wherein caregivers\u2019 mental wellbeing is taken into account to optimize children\u2019s health-related outcomes and behaviors (e.g., treatment adherence). Here, mindfulness and parenting-based programs have been developed to support the mental wellbeing of caregivers and, in turn, promote richer interactions with the children. Nevertheless, this type of program can face drawbacks, such as the scheduling and availability of family members. Recent digital health (DH) solutions (e.g., mobile apps) are showing promising advantages as self-management support tools for improving wellbeing and behaviors related to the treatments. Although, further evidence is necessary in the field of Growth Hormone Treatment\u00a0(GHt). Accordingly, this study aims to examine the usability of a mobile DH solution and the feasibility of a DH intervention designed to promote emotional and mental wellbeing of caregivers of children undergoing GHt.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This is a prospective mixed-methods (qualitative-quantitative) exploratory study composed of two sub-studies, including caregivers of children undergoing GHt. Sub-study one (SS1; n\u2009=\u200910) focuses on the usability of the DH solution (detecting potential barriers and facilitators) and an ad hoc semi-structured interview will be administered to the caregivers after using the DH solution for one month. Sub-study two (SS2; n\u2009=\u200955) aims to evaluate the feasibility of the DH intervention on caregivers\u2019 perceived distress, positive affectivity, mental wellbeing, self-efficacy, together with the children\u2019s quality of life and treatment adherence. All these parameters will be assessed via quantitative methods before and after 3-months of the DH intervention. Usability and engagement will also be assessed during and at the end of the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>It is expected that significant amounts of data will be captured with regards of the feasibility of the DH solution.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>The manuscript provides a complete protocol for a study that will include qualitative and quantitative information about, on one hand, the user-friendliness of the DH solution, and on the other, the effects on caregivers\u2019 emotional, as well as, behavioral parameters in terms of the usability and engagement to the DH solution. The findings will contribute to the evidence planning process for the future adoption of digital health solutions for caregiver support and better health-related outcomes.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> ClinicalTrials.gov, ID: NCT04812665.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12911-022-01935-1","type":"journal-article","created":{"date-parts":[[2022,8,13]],"date-time":"2022-08-13T10:02:42Z","timestamp":1660384962000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Digital health for emotional and self-management support of caregivers of children receiving growth hormone treatment: a feasibility study protocol"],"prefix":"10.1186","volume":"22","author":[{"given":"Sergio","family":"Cervera-Torres","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Francisco Jos\u00e9","family":"N\u00fa\u00f1ez-Benjumea","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Antonio","family":"de Arriba Mu\u00f1oz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irene Alice","family":"Chicchi Giglioli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8165-9904","authenticated-orcid":false,"given":"Luis","family":"Fern\u00e1ndez-Luque","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,8,13]]},"reference":[{"issue":"7","key":"1935_CR1","doi-asserted-by":"publisher","first-page":"1673","DOI":"10.1007\/s11136-017-1529-1","volume":"26","author":"M Brod","year":"2017","unstructured":"Brod M, Alolga SL, Beck JF, Wilkinson L, H\u00f8jbjerre L, Rasmussen MH. 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Annu Rev Psychol. 2017;68:601\u201325.","journal-title":"Annu Rev Psychol"}],"container-title":["BMC Medical Informatics and Decision Making"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12911-022-01935-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12911-022-01935-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12911-022-01935-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,8,13]],"date-time":"2022-08-13T11:03:48Z","timestamp":1660388628000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcmedinformdecismak.biomedcentral.com\/articles\/10.1186\/s12911-022-01935-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,13]]},"references-count":54,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2022,12]]}},"alternative-id":["1935"],"URL":"https:\/\/doi.org\/10.1186\/s12911-022-01935-1","relation":{},"ISSN":["1472-6947"],"issn-type":[{"type":"electronic","value":"1472-6947"}],"subject":[],"published":{"date-parts":[[2022,8,13]]},"assertion":[{"value":"1 May 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 July 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"13 August 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures performed in this study, which involves human participants, will be in accordance with the ethical standards of the Helsinki declaration 1964 and its later amendments or comparable ethical standards. The study poses minimal risk for the participants. The anonymized information collected in the study will be used for research and publication purposes, and always safeguarding the right of privacy and anonymity according to the rules of General Data Protection Regulation (GDPR) of the European Union (EU) 2016\/679. Prior to the commencement of the study at Miguel Servet University Hospital, the protocol has been submitted together with its associated documents (information sheet for the patient and informed consent form) to the CEICA (Aragonese Ethical Committee for Clinical Research). In this regard, a written favorable opinion\/approval of the CEICA has been obtained. The subject\u2019s written informed consent to participate in the study must be given before any study-related activities are carried out. However, in order to comply with local regulations, for 12\u00a0years old children and over, an additional consent will also be mandatory. The ICF must be signed and personally dated by the subject and the site investigator (or designee at the Miguel Servet Hospital). The signed and dated declaration of informed consent will remain at the investigator\u2019s site and must be safely archived by the investigator. A copy of the signed and dated information and consent form will be provided to the subject prior to participation. Adequate information must therefore be given to the subject by the study site investigator or a member of his team before informed consent is obtained. In addition to providing this written information to a potential subject, the investigator or his\/her designee will inform the subject verbally of all pertinent aspects of the study<i> (the language used in doing so must be chosen so that the information can be fully and readily understood by laypersons)<\/i>. According to national regulations in Spain, a designated person by the investigator may inform the subject and sign the Informed Consent Form. To ensure that participants\u2019 anonymity is maintained during the study, a coding system will be used so that a unique code-number will be assigned to each participant at inclusion. This number will also be used as a subject-case identifier in the data sets of the study. On the CRFs or other documents subjects will not be identified by their names, but by their assigned identification numbers. The clinical investigator at the hospital will keep a separate log of subjects\u2019 identification numbers, names, addresses, telephone numbers, and hospital numbers. Documents not for submission to the Sponsor, such as signed Informed Consent Forms, will be maintained in strict confidence by the investigator. Only authorized persons will have access to identifiable personal details if required for data verification. The subject\u2019s original medical data that are reviewed at the site during source data verification by the audits, and Health Authority inspections will be kept strictly confidential. The investigator agrees to provide direct access to these documents to the Sponsor and Health Authority representatives. The investigator is responsible for retrieving information from personal medical records. Data protection and privacy regulations will be observed in capturing, forwarding, processing, and storing subject data. Subjects will be informed accordingly and will be requested to give their consent on data handling procedures in accordance with national regulations.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"LFL, SCT, FJNB and IACG are employee of  Adhera Health Inc., which is a Precision Digital Companion\u2122 company based in Palo Alto (CA, USA). LFL is a shareholder of Adhera Health Inc.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"215"}}