Effectiveness of a Digital Activity Platform for Informal and Formal Caregivers in Long-Term Care Facilities (EngageLTCdigit)
Effectiveness Research on a Digital Engagement Platform in Long- Term Care on Informal and Formal Caregivers [Short Title: EngageLTCdigital]
The purpose of this study is to determine whether a digital engagement platform can support caregivers working in long-term care facilities. The main question is:
Does the use of a digital engagement platform improve person-centred care for older adults living in long-term care facilities? The study includes formal caregivers (such as nursing staff) and informal caregivers (such as volunteers, family members, and civilian service participants) who provide care and support to older adults in long-term care facilities.
One group of participants will use the digital engagement platform as part of their daily care activities. A comparison group will continue with usual care without access to the platform. Participants will take part in the study for 12 weeks and complete questionnaires at several time points. In addition, platform usage data will be collected.
In addition to person-centred care, the study will examine:
- Whether the platform improves caregivers' cultural competence.
- Whether the platform supports the collection and documentation of residents' life history information.
- How often and how long the platform is used by caregivers.
- Caregivers' experiences with and satisfaction with the platform. The findings may help improve digital tools that support caregivers and enhance the quality of care for older adults in long-term care settings.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Background Population aging and the increasing number of older people with cognitive and physical impairments present major challenges for long-term care facilities. At the same time, shortages of nursing and care staff, as well as a decline in informal support, contribute to increasing demands on caregivers. In this context, innovative approaches are needed to support caregivers and promote high-quality person-centred care.Person-centred care focuses on the individual needs, preferences, abilities, and life experiences of residents. Digital technologies may support caregivers in planning and delivering individualized and meaningful activities while enhancing residents' social participation.
Study Objectives The primary objective of this study is to investigate the effects of using the digital engagement platform on person-centred care. In addition, the study will examine caregivers' cultural competence, the collection of residents' biographical information, the frequency and duration of platform use, and users' experiences with the platform. Adverse events occurring during the study period will also be documented.
Intervention This study evaluates the effectiveness of the digital engagement platform "PflegeZeit" in residential long-term care facilities. The platform is used on tablets or other digital devices and provides individualized engagement activities. The intervention is based on three core components: the integration of biographical information and reminiscence, cognitive stimulation, and physical activation. By combining these components, the platform aims to support caregivers in implementing individualized and person-centred engagement activities in everyday care practice.
Control Group The control group will not receive access to the digital engagement platform and will continue routine care practices within their respective long-term care facilities. No additional digital support tools will be provided as part of the study.
Study Population The study targets both formal caregivers (e.g., nursing and care staff) and informal caregivers (e.g., family members, volunteers, or civilian service participants) who provide care and support to residents in residential long-term care facilities.
Defined inclusion and exclusion criteria will be applied to ensure that participants represent the intended target population. Detailed eligibility criteria are provided in the corresponding section of the study registration.
Study Design The study is designed as a multicentre, open-label, quasi-experimental pre-post study with a control group.
Participating long-term care facilities will be assigned to either the intervention group or the control group prior to study initiation. Facilities in the intervention group will implement the digital engagement platform as part of routine care, whereas facilities in the control group will continue providing usual care without the platform. Participants will be observed over a period of 12 weeks. Data collection will take place at four time points: baseline and after 4, 8, and 12 weeks.
Sample Size and Recruitment Participating caregivers will be recruited from four to eight long-term care facilities. The sample size is based on the primary outcome, the group-by-time interaction in the Person-Centred Practice Inventory for Staff (PCPI-S), and was determined using an a priori sample size calculation conducted with G*Power 3.1. The calculation indicated a required sample size of 36 participants. To account for an anticipated dropout rate of up to 15%, a target sample size of 42 caregivers will be recruited. Of these, 21 participants will be allocated to the intervention group and 21 participants to the control group.
Statistical Analysis Data analysis will be conducted according to a predefined statistical analysis plan. Descriptive statistical methods will be used to characterize the study population and study variables. Changes over time and differences between the intervention and control groups will be evaluated using linear mixed-effects models. These analyses will account for both repeated measurements and the clustered structure of the data at the facility level.
Potential Benefits and Risks The use of digital health applications in long-term care has the potential to support caregivers in the delivery of person-centred care. Previous research suggests that digital interventions may positively influence communication, caregivers' job satisfaction, and the social participation of residents. This study aims to provide further evidence regarding the potential benefits of a digital engagement platform in residential long-term care settings.
No specific risks or disadvantages associated with participation in the study or the use of the digital engagement platform are known for caregivers. The platform is used within routine care activities. Any additional burden is limited to the time required for platform use and participation in study-related data collection. Adverse events will be systematically monitored and documented throughout the study.
Expected Contribution The findings of this study are expected to contribute to the evidence base for digital support interventions in long-term care. The results may help identify effective strategies to support caregivers, strengthen person-centred care, and further develop the quality of care for residents in residential long-term care facilities
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Janine Julia Hörzig, BScN, MSc ANP
- Número de telefone: +43 (0)50 344 42421
- E-mail: janine.hoerzig@fhgooe.ac.at
Estude backup de contato
- Nome: Alexander Loidl, BSc
- Número de telefone: +43 664 24 027
- E-mail: alex.loidl@pflege-zeit.at
Locais de estudo
-
-
Upper Austria
-
Bad Hall, Upper Austria, Áustria, 4540
- Recrutamento
- Seniorenwohnhaus Schloss Hall - Caritas OÖ
-
Contato:
- Michaela Hubinger, MSc
- Número de telefone: +43 07258 2574-0
- E-mail: schloss.hall@caritas-ooe.at
-
Engelhartszell, Upper Austria, Áustria, 4090
- Recrutamento
- Langzeitbetreuung Engelhartszell
-
Contato:
- Mag.a Roswitha Reisinger
- Número de telefone: 07717 7840-0
- E-mail: roswitha.reisinger@caritas-ooe.at
-
Kremsmünster, Upper Austria, Áustria, 4550
- Recrutamento
- Bezirksalten- und Pflegeheim Kremsmünster
-
Contato:
- Barbara Peter
- Número de telefone: +43 (0)7583 5111
- E-mail: baph-kremsmuenster.post@shvki.at
-
Linz, Upper Austria, Áustria, 4020
- Recrutamento
- Seniorenwohnhaus St. Anna - Caritas OÖ
-
Contato:
- Jörn Svoboda, B.Sc
- Número de telefone: +43 (0)732 7610-2601
- E-mail: st.anna@caritas-ooe.at
-
Micheldorf in Oberösterreich, Upper Austria, Áustria, 4563
- Recrutamento
- Bezirksalten- und Pflegeheim Micheldorf
-
Contato:
- Ulrike Mayrdorfer, MBA
- Número de telefone: +43(0)7582 62600-2012
- E-mail: baph-micheldorf.post@shvki.at
-
Steyr, Upper Austria, Áustria, 4400
- Recrutamento
- Alten- und Pflegeheim Ennsleite
-
Contato:
- Evelyn Götz
- Número de telefone: 07252-50500
- E-mail: ape.office@steyr.gv.at
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Formal or informal caregivers of nursing home residents
- Setting: Inpatient long-term care facilities in Upper Austria
- Minimum age: 18 years
- Willingness to use a digital app
- Sufficient knowledge of German (at least level B2)
Exclusion Criteria:
- No care for nursing home residents
- Work outside inpatient long-term care facilities (e.g. mobile care, hospital, rehabilitation, assisted living)
- Age: under 18 year
- No willingness to use the digital engagement platform
- Insufficient knowledge of German (below B2 level)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A: Intervention Group (Digital Activation Platform)
The digital activation platform "PflegeZeit" is a tablet-based application used by formal and informal caregivers in long-term care facilities to support individualized engagement activities for residents.
The platform combines biographical engagement and reminiscence, cognitive activation, and physical activation.
It is used as part of routine care during the 12-week study period.
Frequency and duration of use are determined according to individual care needs and routine care practices.
Platform usage data are automatically recorded.
|
The intervention is based on three core pillars: (1) promoting familiarity and biographical engagement through content reflecting residents' life context (e.g., traditions, music, and image-based materials); (2) supporting cognitive activation through individually adaptable memory and problem-solving tasks as well as sensory exercises; and (3) enhancing physical and psychosocial resources through movement based activities, including chair-based exercises, group activities, and guided physical exercises.
|
|
Sem intervenção: Arm B: Control Group (Usual Care)
The control group will receive standard care, consisting of routine care services without access to the digital activation platform.
Care providers will continue their usual activities and utilize the programs available within the facilities (digital or print-based).
They will be involved in shaping the care process of the residents and will document all nursing interventions in accordance with the legal requirements of the Health and Nursing Care Act (GuKG), including nursing assessment, nursing diagnoses, care planning, and nursing interventions.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To examine the effects of a digital engagement platform on person-centred care.
Prazo: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
Mean change in indicators of person-centred care associated with the use of the digital engagement platform in nursing homes, estimated with the instrument Person-Centred Practice Inventory - Staff (PCPI-S).
|
Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
To examine the effects of the digital engagement platform on caregivers' cultural competence.
Prazo: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
Mean change in caregivers' cultural competence associated with the use of the digital engagement platform for nursing home residents estimated with CCA-A German Version. CCA-A German Version: is a questionnaire that assesses the cultural competences of the caregivers. |
Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
|
To examine the effects of the digital engagement platform on caregivers' adherence to biographical information entry.
Prazo: Measured at Baseline (Day 1) and Visit 3 at Month 3 (Day 84).
|
Mean change in caregivers' adherence to biographical information entry within the database of the nursing home, estimated using predefined questionnaire on number of words in the database.
|
Measured at Baseline (Day 1) and Visit 3 at Month 3 (Day 84).
|
|
To examine the effects of the digital engagement platform on duration and intensity of use by caregivers.
Prazo: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
|
Mean change in duration and frequency of use of the digital engagement platform by caregivers, estimated using system-generated usage metrics.
|
Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
|
|
To examine the effects of the digital engagement platform on caregivers' user experience.
Prazo: Measured at Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
Mean change in caregivers' user experience with the digital engagement platform, estimated with the UEQ-S
|
Measured at Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).
|
|
A standardized form will be used to document adverse events (AEs) occurring during the study procedures.
Prazo: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
|
Number of adverse events estimated via a AE form sheet.
|
Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).
|
Colaboradores e Investigadores
Investigadores
- Cadeira de estudo: FH-Prof. Aff. Hon. Asst. Prof. Dr. Bernhard h Schwartz, BSc MSc, University of Applied Sciences for Health Professions Upper Austria
Publicações e links úteis
Links úteis
- Osmancevic, S., Großschädl, F., Stijic, M., & Lohrmann, C. (2022). The German version of the Cultural Competence Assessment (CCA-G): Cross-cultural adaptation and validation study in Austrian acute care settings. BMC Nursing, 21(77), 1-10.
- PflegeZeit. (2025b). Unsere Funktionen.
- McCormack, B. G., Slater, P. F., Gilmour, F., Edgar, D., Gschwenter, S., McFadden, S., Hughes, C., Wilson, V., & McCance, T. (2024). The development and structural validity testing of the Person-centred Practice Inventory-Care (PCPI-C). PLOS ONE, 19(5)
- GÖG. (2025). Österreichischer Demenzbericht 2025.
- Bundesministerium für Soziales, Gesundheit, Pflege und Konsumentenschutz (BMSGPK). (Juni, 2021). Menschen mit Demenz und (assistive) Technologie: Perspektive der Betroffenen und ihrer informellen und formellen Betreuungs- und Pflegepersonen im häuslich
- Langenberger, B., Baier, N., Hanke, F.-C., Fahrentholz, J., Gorny, C., Sehlen, S., Reber, K. C., Liersch, S., Radomski, R., Haftenberger, J., Heppner, H. J., Busse, R., & Vogt, V. (2021).The detection and prevention of adverse drug events in nursing ho
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- P-2025-022
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .