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Age Problem24h-quAALityNCT04581538

Digital Support for Quality Assurance in 24-hour Caregiving at Home

A study testing Intervention of parallel arm 2 and Intervention of parallel arm 3 in people with Age Problem, run by Peter Putz at 4 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Age Problem
What is being tested?
Intervention of parallel arm 2 and Intervention of parallel arm 3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
4 sitesAustria
Study dates
5 Oct 2020to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Austria4 sites

  • Home-Care-Management ALEXANDER WINTER e.U.

    Breitstetten, 2285

  • CARITAS Rundum zu Hause betreut

    Vienna, 1040

  • ipb - Institut für Personenbetreuung

    Vienna, 1090

  • Johanniter Österreich Ausbildung und Forschung gem. GmbH

    Vienna, 1210

Other trials in Austria

About this study

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

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. Due to the cost-efficiency and 24-hour availability, the 24-hour home care represents a cornerstone of the care of older people and, with more than 60.000 users in Austria, it represents an important alternative to family assistance and mobile care. Care receivers range from elderly people, who only need assistance with household activities, to those with a high need for a round-the-clock care. Caregivers commute between Austria and the respective home country (mainly Slovakia, Hungary and Romania) for the care work in a two or more weeks rhythm. Burdensome working conditions arise mainly due to language problems, isolated coexistence with a person affected by e.g. dementia in combination with little to no relevant professional education and quality control.

The aim of the project is the development and evaluation of a distributed client-server software solution for the support and quality assurance of 24-hour home care. The application software contains:

  1. an information and education portal (e-learning platform) with interactive learning content on common diseases and short videos on recurrent care situations in German, as well as in Slovak, Hungarian and Romanian as the most frequent languages of the caregivers.
  2. a comprehensive electronic care documentation that supports quality assurance and ensures transparency between people involved.
  3. an integrated emergency management, which offers caregivers the opportunity to react quickly and professionally to emergencies.
  4. links to translation pages or networking opportunities with members and relatives.

By using the application software, the quality of care will be supported and further result in an increase of care quality and quality of life of the older adults cared for. Due to intense longitudinal evaluation design with more than 100 involved households facilitating 24-hour home care for a period of 12 months, the efficacy will be measured multi-dimensionally. Common surveys and structured interviews of people with cognitive impairments tend to lack sensitivity to the interventions studied. Hence, a mixed-method approach has been selected that integrates 1) investigator observations, 2) interviews with caregivers, 3) interviews with relative and 4) interviews with care receivers (where possible). Trained investigators generate reliable ratings via triangulation. Field work and analysis follows the methodology developed as Toolkit ASCOT (Adult Social Care Outcomes Toolkit 11) SCT4 (self completion survey).

Conditions
Age Problem
Being tested
Intervention of parallel arm 2, Intervention of parallel arm 3
Keywords
elderly, 24-hour home care, e-learning, digital care documentation, emergency management, active and assisted living
Medical subject headings
Motor Activity

What participants receive

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

  • Intervention of parallel arm 2Device

    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.

  • Intervention of parallel arm 3Device

    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.

Study groups in NCT04581538
Study groupRoleWhat they receive
Control groupNo interventionThis arm is being provided with continued home care as it was before
E-learning platform & networking platformExperimentalThis arm is being provided with the e-learning platform and networking platform as components of the 24-h-quAALity package
Receives: Device: Intervention of parallel arm 2
Entire interventionExperimentalThis arm is being provided with the entire intervention (e-learning platform, networking platform and digital care documentation)
Receives: Device: Intervention of parallel arm 3

What is being measured

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

  1. 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.

    Measured: Baseline

  2. 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

    Measured: 3 Month Follow-Up

  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.ASCOT Domain Scores related to Care Receivers

    Measured: 12 Month Follow-Up

Secondary outcomes (19)

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

    Metric scale. Standardized metric score ranging from 0 to 1, where 1 is ideal.

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

  2. 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

    Metric scale. Standardized metric score ranging from 0 to 1, where 1 is ideal.

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

  3. 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

    Metric scale. Standardized metric score ranging from 0 to 1, where 1 is ideal.

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

  4. 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

    Metric scale. Standardized metric score ranging from 0 to 1, where 1 is ideal.

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

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

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  6. ASCOT SCT4 - Domain Score for Food and Drink related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  7. ASCOT SCT4 - Domain Score for Accommodation Cleanliness and Comfort related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  8. ASCOT SCT4 - Domain Score for Personal Safety related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  9. Domain Score for Social Participation and Involvement related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  10. ASCOT SCT4 - Domain Score for Occupation related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  11. ASCOT SCT4 - Domain Score for Control over Daily Life related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  12. ASCOT SCT4 - Domain Score for Dignity related to Care Receivers

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  13. ASCOT SCT4 Instrument for Caregivers - Domain Occupation

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  14. ASCOT SCT4 Instrument for Caregivers - Domain Control over daily life

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  15. ASCOT SCT4 Instrument for Caregivers - Domain Looking after yourself

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  16. ASCOT SCT4 Instrument for Caregivers - Domain Personal safety

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  17. ASCOT SCT4 Instrument for Caregivers - Domain Participation and involvement

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  18. ASCOT SCT4 Instrument for Caregivers - Domain Space and time to be yourself

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

  19. ASCOT SCT4 Instrument for Caregivers - Domain Feeling supported and encouraged

    4-point scale, indicating (aimed for as closely as possible): 1...ideal, 2…no needs, 3…some needs, 4...high needs

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

Timeline

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

  1. First posted9 Oct 2020
  2. Study start5 Oct 2020
  3. Primary completion31 Oct 2021
  4. Study completion31 Oct 2021

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04581538
Sponsor's protocol ID
AAL01
Acronym
24h-quAALity
Status last verified
Mar 2022
First submitted
28 Sep 2020
Last updated
17 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication, upon request

Publications

  • 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.

    PubMed 37974112

Questions about this trial

What is this clinical trial studying?

A study testing Intervention of parallel arm 2 and Intervention of parallel arm 3 in people with Age Problem, run by Peter Putz at 4 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04581538, which also lists 1 linked publication.

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 17 Mar 2022.

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