PMID- 35315784 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220716 IS - 1929-0748 (Print) IS - 1929-0748 (Electronic) IS - 1929-0748 (Linking) VI - 11 IP - 3 DP - 2022 Mar 22 TI - Development of a Digital Health Intervention for Rheumatoid Arthritis Symptom Management in a Biotechnology Industry Context: Protocol for the Application of a Human-Centered Design Framework. PG - e16430 LID - 10.2196/16430 [doi] LID - e16430 AB - BACKGROUND: Involving chronically ill patients in the management of their health is widely recognized as a vital component of high-quality health care. However, to assume the role of informed participants, patients need both access to their health information and assistance in interpreting such data. Smartphone technology with SMS text messaging functionality offers a convenient and minimally demanding mechanism for providing such dual capabilities to patients. To date, a number of similar digital tools have been developed for use in various chronic and progressive disease conditions, including rheumatoid arthritis. OBJECTIVE: This paper aims to describe the development of a research protocol that applies a human-centered design (HCD) approach to develop a mobile health (mHealth) intervention to support symptom management and treatment adherence for rheumatoid arthritis. METHODS: To guide the development of the mHealth intervention for use within a commercial biotechnology context, we selected and applied an HCD framework consisting of three phases: understanding, ideation, and implementation. RESULTS: Leveraging the framework, we mapped the key objectives and research questions to each phase and identified the HCD techniques and methods most suitable for addressing them. In addition, we identified the need to include a fourth phase, one that referred to postimplementation assessment, which would enable evaluation of patient engagement and intervention impact on symptom self-management. CONCLUSIONS: This paper presents a research protocol that applied an HCD framework to guide the development of an mHealth intervention within a commercial biotechnology context. This type of guidance is salient because commercial entities are becoming one of the leading producers of this type of intervention. However, the methodologies used and challenges faced from a research and development perspective are not well-represented in the published research literature to date. Our application of the HCD framework yielded important findings. Each phase of the HCD framework provided important guidance for increasing the likelihood that the final product would be understandable, acceptable, feasible, and engaging to use. Consistent with other researchers in the field of mHealth interventions, we identified the need to add a fourth phase to the HCD framework, one that focused on a postimplementation assessment to guide further improvements to support adoption in real-world settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/16430. CI - (c)Lisa Nugent, Robin Anthony Kouyate, Shawna Jackson, Meredith Y Smith. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 22.03.2022. FAU - Nugent, Lisa AU - Nugent L AUID- ORCID: 0000-0002-4219-9439 AD - Amgen, Thousand Oaks, CA, United States. FAU - Anthony Kouyate, Robin AU - Anthony Kouyate R AUID- ORCID: 0000-0003-1554-6332 AD - Amgen, Thousand Oaks, CA, United States. FAU - Jackson, Shawna AU - Jackson S AUID- ORCID: 0000-0002-3220-3369 AD - Amgen, Thousand Oaks, CA, United States. FAU - Smith, Meredith Y AU - Smith MY AUID- ORCID: 0000-0003-4542-5099 AD - Amgen, Thousand Oaks, CA, United States. LA - eng PT - Journal Article DEP - 20220322 PL - Canada TA - JMIR Res Protoc JT - JMIR research protocols JID - 101599504 PMC - PMC8984827 OTO - NOTNLM OT - data visualization OT - digital journal OT - human-centered design OT - mobile phone OT - patient diaries OT - patient-reported outcomes OT - rheumatoid arthritis COIS- Conflicts of Interest: At the time that this manuscript was developed, SJ, LN, RAK, and MYS were full-time employees of Amgen Inc and held shares in the company. EDAT- 2022/03/23 06:00 MHDA- 2022/03/23 06:01 PMCR- 2022/03/22 CRDT- 2022/03/22 12:11 PHST- 2019/09/28 00:00 [received] PHST- 2021/01/19 00:00 [accepted] PHST- 2021/01/15 00:00 [revised] PHST- 2022/03/22 12:11 [entrez] PHST- 2022/03/23 06:00 [pubmed] PHST- 2022/03/23 06:01 [medline] PHST- 2022/03/22 00:00 [pmc-release] AID - v11i3e16430 [pii] AID - 10.2196/16430 [doi] PST - epublish SO - JMIR Res Protoc. 2022 Mar 22;11(3):e16430. doi: 10.2196/16430.