NCT07780071

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2026Apr 2027

First Submitted

Initial submission to the registry

August 10, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 10, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

caregiverslong-term careperson-centered caredigital activity platform

Outcome Measures

Primary Outcomes (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 at Baseline (Day 1), Month 1 (Day 28), Month 2 (Day 56), and Month 3 (Day 84).

Secondary Outcomes (5)

  • To examine the effects of the digital engagement platform on caregivers' cultural competence.

    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.

    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.

    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.

    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.

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

Study Arms (2)

Arm A: Intervention Group (Digital Activation Platform)

EXPERIMENTAL

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.

Other: PflegeZeit - den Menschen sehen.

Arm B: Control Group (Usual Care)

NO INTERVENTION

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.

Interventions

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.

Arm A: Intervention Group (Digital Activation Platform)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Seniorenwohnhaus Schloss Hall - Caritas OÖ

Bad Hall, Upper Austria, 4540, Austria

RECRUITING

Langzeitbetreuung Engelhartszell

Engelhartszell, Upper Austria, 4090, Austria

RECRUITING

Bezirksalten- und Pflegeheim Kremsmünster

Kremsmünster, Upper Austria, 4550, Austria

RECRUITING

Seniorenwohnhaus St. Anna - Caritas OÖ

Linz, Upper Austria, 4020, Austria

RECRUITING

Bezirksalten- und Pflegeheim Micheldorf

Micheldorf in Oberösterreich, Upper Austria, 4563, Austria

RECRUITING

Alten- und Pflegeheim Ennsleite

Steyr, Upper Austria, 4400, Austria

RECRUITING

Related Links

Study Officials

  • FH-Prof. Aff. Hon. Asst. Prof. Dr. Bernhard h Schwartz, BSc MSc

    University of Applied Sciences for Health Professions Upper Austria

    STUDY CHAIR

Central Study Contacts

Janine Julia Hörzig, BScN, MSc ANP

CONTACT

Alexander Loidl, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Janine Julia Hörzig BScN MSc (ANP)

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 21, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individuals data will not be shared, because of the European General Data protection regulation. Group-wise results might be shared.

Locations