AzTrials
AzTrials

EngagementEngageLTCdigitNCT07780071

Effectiveness of a Digital Activity Platform for Informal and Formal Caregivers in Long-Term Care Facilities

A study testing PflegeZeit - den Menschen sehen. in people with Engagement and Nursing Care, run by University of Applied Sciences for Health Professions Upper Austria at 6 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Engagement, Nursing Care, Digital Application
What is being tested?
PflegeZeit - den Menschen sehen.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
6 sitesAustria
Study dates
Sep 2026to Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Janine Julia Hörzig, BScN, MSc ANP contact

+43 (0)50 344 42421

janine.hoerzig@fhgooe.ac.at

Alexander Loidl, BSc contact

+43 664 24 027

alex.loidl@pflege-zeit.at

6 sites in 1 country

Austria6 sites, 6 recruiting
  • Seniorenwohnhaus Schloss Hall - Caritas OÖ

    Bad Hall, Upper Austria, 4540

    Michaela Hubinger, MSc, +43 07258 2574-0, schloss.hall@caritas-ooe.at

    Recruiting
  • Langzeitbetreuung Engelhartszell

    Engelhartszell, Upper Austria, 4090

    Mag.a Roswitha Reisinger, 07717 7840-0, roswitha.reisinger@caritas-ooe.at

    Recruiting
  • Bezirksalten- und Pflegeheim Kremsmünster

    Kremsmünster, Upper Austria, 4550

    Barbara Peter, +43 (0)7583 5111, baph-kremsmuenster.post@shvki.at

    Recruiting
  • Seniorenwohnhaus St. Anna - Caritas OÖ

    Linz, Upper Austria, 4020

    Jörn Svoboda, B.Sc, +43 (0)732 7610-2601, st.anna@caritas-ooe.at

    Recruiting
  • Bezirksalten- und Pflegeheim Micheldorf

    Micheldorf in Oberösterreich, Upper Austria, 4563

    Ulrike Mayrdorfer, MBA, +43(0)7582 62600-2012, baph-micheldorf.post@shvki.at

    Recruiting
  • Alten- und Pflegeheim Ennsleite

    Steyr, Upper Austria, 4400

    Evelyn Götz, 07252-50500, ape.office@steyr.gv.at

    Recruiting

Other trials in Austria

About this study

Official title: 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.

Read more

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.
Read the detailed description

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

Being tested
PflegeZeit - den Menschen sehen.
Keywords
caregivers, long-term care, person-centered care, digital activity platform

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PflegeZeit - den Menschen sehen.Other

    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.

Study groups in NCT07780071
Study groupRoleWhat they receive
Arm A: Intervention Group (Digital Activation Platform)ExperimentalThe 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.
Receives: Other: PflegeZeit - den Menschen sehen.
Arm B: Control Group (Usual Care)No interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To examine the effects of a digital engagement platform on person-centred care.

    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: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

Secondary outcomes (5)
  1. To examine the effects of the digital engagement platform on caregivers' cultural competence.

    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: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

  2. To examine the effects of the digital engagement platform on caregivers' adherence to biographical information entry.

    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: Measured at Baseline (Day 1) and Visit 3 at Month 3 (Day 84).

  3. To examine the effects of the digital engagement platform on duration and intensity of use by caregivers.

    Mean change in duration and frequency of use of the digital engagement platform by caregivers, estimated using system-generated usage metrics.

    Measured: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).

  4. To examine the effects of the digital engagement platform on caregivers' user experience.

    Mean change in caregivers' user experience with the digital engagement platform, estimated with the UEQ-S

    Measured: Measured at Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

  5. A standardized form will be used to document adverse events (AEs) occurring during the study procedures.

    Number of adverse events estimated via a AE form sheet.

    Measured: Continuously monitored from Baseline (Day 1) through the end of the 3-month study period (Day 84).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionMar 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This study is a multicenter, open-label, quasi-experimental study with a control group. The design corresponds to a non-randomized controlled trial in which pre-existing groups are compared without random allocation. Nursing homes with access to the digital activation platform comprise the intervention group, in which care staff use the platform as part of routine care with residents in long-term care settings. Nursing homes without access to the platform comprise the control group and continue usual care during the study period.
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07780071
Sponsor's protocol ID
P-2025-022
Acronym
EngageLTCdigit
Status last verified
Aug 2026
First submitted
10 Aug 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individuals data will not be shared, because of the European General Data protection regulation. Group-wise results might be shared.

Questions about this trial

What is this clinical trial studying?

A study testing PflegeZeit - den Menschen sehen. in people with Engagement and Nursing Care, run by University of Applied Sciences for Health Professions Upper Austria at 6 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janine Julia Hörzig, BScN, MSc ANP (+43 (0)50 344 42421, janine.hoerzig@fhgooe.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To examine the effects of a digital engagement platform on person-centred care. (time frame: Measured at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in