NCT04581538

Brief Summary

Due to the demographic change, there is a growing demand for professional and institutional care, as well as the need for 24-hour home care. Care receivers range from elderly people, in need of assistance with household activities only, to those with a comprehensive need for round-the-clock care. Caregivers commute between Austria and their respective home country (mainly Slovakia, Hungary and Romania) in a two or more weeks cycle. Burdensome working conditions arise mainly due to language problems, isolated coexistence with a person affected by e.g. dementia, in combination with limited professional education and quality control. The aim of the project is the development and evaluation of a software solution for the support and quality assurance of 24-hour home care. The application software contains:

  1. 1.an information and education portal (e-learning platform)
  2. 2.a comprehensive electronic care documentation
  3. 3.an integrated emergency management
  4. 4.links to translation pages or networking opportunities with members and relatives

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

October 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

September 28, 2020

Last Update Submit

March 16, 2022

Conditions

Keywords

elderly24-hour home caree-learningdigital care documentationemergency managementactive and assisted living

Outcome Measures

Primary Outcomes (3)

  • ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers

    Metric scale. Standardized metric score ranging from -0.17 to 1, where "0" is equivalent to dead and "1" is ideal.

    Baseline

  • ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers

    Metric scale. Standardized metric score ranging from -0.17 to 1, where "0" is equivalent to dead and "1" is ideal.ASCOT Domain Scores related to Care Receivers

    3 Month Follow-Up

  • ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers

    Metric scale. Standardized metric score ranging from -0.17 to 1, where "0" is equivalent to dead and "1" is ideal.ASCOT Domain Scores related to Care Receivers

    12 Month Follow-Up

Secondary Outcomes (19)

  • ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of seven ASCOT Instrument for Caregivers Scores

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • Project specific self-rated satisfaction and usefulness related to electronic care documentation, professional skills and qualification, and interconnectedness and communication - Summary Score of 14 project specific questions for Caregivers

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • Project specific self-rated satisfaction and usefulness related to electronic care documentation, care quality and conditions, and interconnectedness and communication - Summary Score of 7 project specific questions for Relatives of Care Receivers

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • Project specific self-rated satisfaction and usefulness related to electronic care documentation, and interconnectedness and communication - Summary Score of 4 project specific questions for Nurses

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • ASCOT (Adult Social Care Outcome Toolkit) SCT4 - Domain Score for Personal Cleanliness and Comfort related to Care Receivers

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • +14 more secondary outcomes

Other Outcomes (3)

  • Self-perceived health of Care Receivers as specified by the European Core Health Indicators (ECHI short list)

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

  • Frequency of change of Caregivers

    Metric scale. Annualized rate, recorded by investigator.

  • Geriatric Depression Scale (GDS) Geriatric Depression Scale (GDS) of Care Receivers

    Baseline, 3 Month Follow-Up, 12 Month Follow-Up

Study Arms (3)

Control group

NO INTERVENTION

This arm is being provided with continued home care as it was before

E-learning platform & networking platform

EXPERIMENTAL

This arm is being provided with the e-learning platform and networking platform as components of the 24-h-quAALity package

Device: Intervention of parallel arm 2

Entire intervention

EXPERIMENTAL

This arm is being provided with the entire intervention (e-learning platform, networking platform and digital care documentation)

Device: Intervention of parallel arm 3

Interventions

This intervention consists of the e-learning platform and the networking platform from the newly developed client-server software solution "24-h-QuAALity". The e-learning platform offers concise evidence-based information on common clinical patterns, as well as examples of assistance, physical activity, nutrition and daily routine provided in the caregivers' mother tongues.The caregivers use the e-learning content according to the needs of their clients and their caring skills. After completing the e-learning courses they do a test to prove their knowledge. The networking platform supports caregivers in communicating with other caregivers and relatives of the care receiver, with special consideration of language barriers. The caregivers use the networking platform primarily to get information or exchange it, if there are uncertainties in the care.

E-learning platform & networking platform

Intervention Description: This interventions represents the entire 24-h-QuAALity package consisting of the e-learning platform and networknig platform as specified under "intervention 1" and the digital care documentation from the newly developed client-server software solution "24-h-QuAALity". The digital care documentation aims at supporting caregivers in managing their daily tasks and facilitates exchange with other health professionals and palliative supply. The caregivers use the care documentation every day. They describe the caring and household activities they have done by their clients. The integrated emergency management empowers caregivers with lifesaving first aid skills and knowledge including an integrated voice communication and emergency call system. The emergency management system is used by caregivers when an emergency happens in which life-threatening diseases have to be managed.

Entire intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Household with 24-hour-care service
  • Household located in the federal territory of Austria
  • Caregiver able and willing to comply with all study related procedures and giving informed consent
  • Age 55+ years for care receivers

You may not qualify if:

  • Death of care receiver
  • Termination of 24-hour-care, due to other reasons than death of care receiver
  • Interruption of 24-hour-care for at least 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Home-Care-Management ALEXANDER WINTER e.U.

Breitstetten, 2285, Austria

Location

CARITAS Rundum zu Hause betreut

Vienna, 1040, Austria

Location

ipb - Institut für Personenbetreuung

Vienna, 1090, Austria

Location

Johanniter Österreich Ausbildung und Forschung gem. GmbH

Vienna, 1210, Austria

Location

Related Publications (1)

  • Haslinger-Baumann E, Putz P, Hauser C, Kupka-Klepsch E, Sturm N, Werner F. Digital support for quality assurance in 24-hour caregiving at home: a randomized controlled trial investigating the effects on quality of life and professional skills of paid 24h-caregivers. BMC Geriatr. 2023 Nov 17;23(1):750. doi: 10.1186/s12877-023-04454-4.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Elisabeth Haslinger-Bauman, PhD

    FH Campus Wien, University of Applied Sciences

    PRINCIPAL INVESTIGATOR
  • Franz Werner, PhD

    FH Campus Wien, University of Applied Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Three parallel arms investigate 1) the control group, where home care is being continued as before, 2) combined effects of the e-learning platform and the networking platform, and 3) effects of the entire intervention (e-learning platform, networking platform, digital care documentation). The interventions last 12 months, with effects being investigated in two follow-ups after three and 12 months. The main one-sided alternative hypothesis, assumes a positive trend from 1 ) towards 3) in the outcomes studied. Planned contrasts are: 1. control vs. experimental arm 3 (indicating effects of the entire experimental intervention) 2. arm 2 vs. arm 3 (indicating whether arm 3 has additional effects as compared to arm 2) Planned contrasts are ignored, if the overall null hypothesis is not rejected in the ANOVA.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research & Development

Study Record Dates

First Submitted

September 28, 2020

First Posted

October 9, 2020

Study Start

October 5, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication, upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Starting 6 months after publication
Access Criteria
Researchers for non-commercial purposes

Locations