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Peer-reviewedCC BY 4.0Journal of Medical Internet Research

Early-Stage Co-Creation and Human-Centered Development of Digital Therapeutics for Cognitive Rehabilitation in Early Neurocognitive Disorders: Convergent Mixed Methods Study

  1. 1IRCCS Fondazione Don Carlo Gnocchi, Via Capecelatro 66, Milan, 20148, Italy, +39 0240308952

Abstract

Background: Subjective cognitive decline (SCD) and mild cognitive impairment (MCI) represent critical windows for early neurocognitive intervention, although access to timely, personalized rehabilitation remains limited. Digital health technologies offer opportunities to deliver scalable and individualized cognitive care; however, their successful implementation depends on an understanding of users’ needs, expectations, and barriers. Within a human-centered design (HCD) framework, actively involving end users during the earliest stages of development is essential to ensure that digital rehabilitation is acceptable, usable, and responsive to real-world rehabilitation needs.

Objective: This study explores the experiences, rehabilitation needs, perceptions, and challenges of individuals with SCD and MCI regarding cognitive telerehabilitation. The findings are intended to inform the early-stage co-creation and human-centered development of digital rehabilitation solutions.

Methods: The study is framed within an HCD perspective to inform the user-centered development of digital rehabilitation solutions. A convergent mixed methods design was adopted to integrate quantitative assessments with qualitative interviews. The semistructured interview explored 4 thematic domains: neurocognitive abilities, network support, user experience and engagement, and digital divide. Twenty-three individuals with SCD or MCI completed the interview together with measures including the Montreal Cognitive Assessment (MoCA), Cognitive Failures Questionnaire (CFQ), and an ad hoc Technological Expertise questionnaire. Qualitative interview data were analyzed using directed content analysis based on 4 predefined thematic domains by 2 independent raters, with interrater agreement assessed using Cohen κ. Qualitative and quantitative findings were subsequently integrated through exploratory Mann-Whitney U tests.

Results: Twenty-three participants (n=16 female participants; mean age 74.3, SD 7.35 y) were included. Participants reported preserved cognitive performance (MoCA: mean 24.9, SD 3.23), low-to-moderate perceived cognitive difficulties (CFQ: mean 22.4, SD 9.48), and moderate technological familiarity. Qualitative findings revealed memory (n=12, 52.2%), attention/executive (n=6, 26.1%), and language (n=4, 17.4%) difficulties during everyday activities, together with widespread use of compensatory strategies. Participants also described emotional vulnerability, social withdrawal, and feelings of misunderstanding, as well as delayed rehabilitation access despite reporting cognitive concerns to health care professionals. Although most participants had limited prior knowledge of telerehabilitation, they expressed a positive attitude toward home-based rehabilitation, valuing its convenience, flexibility, autonomy, and accessibility when appropriate technological and clinical support was available. Concerns mainly related to limited supervision, technical barriers, and digital literacy. Mixed methods integration showed that perceived technology-related barriers were associated with lower technological competence (median 1.88, IQR 1.69‐2.56 vs median 3.06, IQR 2.75‐3.59; P=.002), while no other significant differences emerged.

Conclusions: These findings highlight that effective digital rehabilitation should be developed through iterative, user-informed HCD processes that simultaneously address cognitive, emotional, social, and technological dimensions of early neurocognitive decline. Integrated findings highlight the importance of addressing individual needs and incorporating users’ perspectives from the earliest design phases to support usable, engaging, and accessible digital rehabilitation solutions.

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BibTeX
@article{rossetto2026earlystage,
  title = {{Early-Stage Co-Creation and Human-Centered Development of Digital Therapeutics for Cognitive Rehabilitation in Early Neurocognitive Disorders: Convergent Mixed Methods Study}},
  author = {Federica Rossetto and Francesca Borgnis and Chiara Mangione and Claudia Serenelli and Sara Isernia and Francesca Baglio},
  journal = {Journal of Medical Internet Research},
  year = {2026},
  month = nov,
  doi = {10.2196/98625},
  url = {https://doi.org/10.2196/98625},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Early-Stage Co-Creation and Human-Centered Development of Digital Therapeutics for Cognitive Rehabilitation in Early Neurocognitive Disorders: Convergent Mixed Methods Study
AU  - Federica Rossetto
AU  - Francesca Borgnis
AU  - Chiara Mangione
AU  - Claudia Serenelli
AU  - Sara Isernia
AU  - Francesca Baglio
PY  - 2026
DA  - 2026/11/03
JO  - Journal of Medical Internet Research
DO  - 10.2196/98625
UR  - https://doi.org/10.2196/98625
AB  - Background: Subjective cognitive decline (SCD) and mild cognitive impairment (MCI) represent critical windows for early neurocognitive intervention, although access to timely, personalized rehabilitation remains limited. Digital health technologies offer opportunities to deliver scalable and individualized cognitive care; however, their successful implementation depends on an understanding of users’ needs, expectations, and barriers. Within a human-centered design (HCD) framework, actively involving end users during the earliest stages of development is essential to ensure that digital rehabilitation is acceptable, usable, and responsive to real-world rehabilitation needs.  Objective: This study explores the experiences, rehabilitation needs, perceptions, and challenges of individuals with SCD and MCI regarding cognitive telerehabilitation. The findings are intended to inform the early-stage co-creation and human-centered development of digital rehabilitation solutions.  Methods: The study is framed within an HCD perspective to inform the user-centered development of digital rehabilitation solutions. A convergent mixed methods design was adopted to integrate quantitative assessments with qualitative interviews. The semistructured interview explored 4 thematic domains: neurocognitive abilities, network support, user experience and engagement, and digital divide. Twenty-three individuals with SCD or MCI completed the interview together with measures including the Montreal Cognitive Assessment (MoCA), Cognitive Failures Questionnaire (CFQ), and an ad hoc Technological Expertise questionnaire. Qualitative interview data were analyzed using directed content analysis based on 4 predefined thematic domains by 2 independent raters, with interrater agreement assessed using Cohen κ. Qualitative and quantitative findings were subsequently integrated through exploratory Mann-Whitney U tests.  Results: Twenty-three participants (n=16 female participants; mean age 74.3, SD 7.35 y) were included. Participants reported preserved cognitive performance (MoCA: mean 24.9, SD 3.23), low-to-moderate perceived cognitive difficulties (CFQ: mean 22.4, SD 9.48), and moderate technological familiarity. Qualitative findings revealed memory (n=12, 52.2%), attention/executive (n=6, 26.1%), and language (n=4, 17.4%) difficulties during everyday activities, together with widespread use of compensatory strategies. Participants also described emotional vulnerability, social withdrawal, and feelings of misunderstanding, as well as delayed rehabilitation access despite reporting cognitive concerns to health care professionals. Although most participants had limited prior knowledge of telerehabilitation, they expressed a positive attitude toward home-based rehabilitation, valuing its convenience, flexibility, autonomy, and accessibility when appropriate technological and clinical support was available. Concerns mainly related to limited supervision, technical barriers, and digital literacy. Mixed methods integration showed that perceived technology-related barriers were associated with lower technological competence (median 1.88, IQR 1.69‐2.56 vs median 3.06, IQR 2.75‐3.59; P=.002), while no other significant differences emerged.  Conclusions: These findings highlight that effective digital rehabilitation should be developed through iterative, user-informed HCD processes that simultaneously address cognitive, emotional, social, and technological dimensions of early neurocognitive decline. Integrated findings highlight the importance of addressing individual needs and incorporating users’ perspectives from the earliest design phases to support usable, engaging, and accessible digital rehabilitation solutions.
SN  - 1439-4456
SN  - 1438-8871
ER  -