Clinical trial NCT04581538: Digital Support for Quality Assurance in 24-hour Caregiving at Home
Official title: Digital Support for Quality Assurance in 24-hour Caregiving at Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age Problem
Keywords: elderly
24-hour home care
e-learning
digital care documentation
emergency management
active and assisted living
Lead sponsor: FH Campus Wien, University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: NOUS Wissensmanagement GmbH
name: Johanniter Österreich Ausbildung und Forschung gem. GmbH
name: CARITAS Rundum zu Hause betreut
name: Österreichischer Gesundheits- und Krankenpflegeverband
name: ipb - Institut für Personenbetreuung
name: Home-Care-Management ALEXANDER WINTER e.U.
First posted: 2020-10-09
Enrollment: 72
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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. 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

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers
timeFrame: Baseline
measure: ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers
timeFrame: 3 Month Follow-Up
measure: ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of eight ASCOT Domain Scores related to Care Receivers
timeFrame: 12 Month Follow-Up
Secondary outcomes:
measure: ASCOT (Adult Social Care Outcome Toolkit) SCT4 value - Summary Score of seven ASCOT Instrument for Caregivers Scores
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: 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
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: 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
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: 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
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT (Adult Social Care Outcome Toolkit) SCT4 - Domain Score for Personal Cleanliness and Comfort related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Food and Drink related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Accommodation Cleanliness and Comfort related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Personal Safety related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: Domain Score for Social Participation and Involvement related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Occupation related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Control over Daily Life related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 - Domain Score for Dignity related to Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Occupation
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Control over daily life
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Looking after yourself
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Personal safety
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Participation and involvement
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Space and time to be yourself
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: ASCOT SCT4 Instrument for Caregivers - Domain Feeling supported and encouraged
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Other outcomes:
measure: Self-perceived health of Care Receivers as specified by the European Core Health Indicators (ECHI short list)
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
measure: Frequency of change of Caregivers
timeFrame: Metric scale. Annualized rate, recorded by investigator.
measure: Geriatric Depression Scale (GDS) Geriatric Depression Scale (GDS) of Care Receivers
timeFrame: Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Locations:
city: Breitstetten
country: Austria
facility: Home-Care-Management ALEXANDER WINTER e.U.
city: Vienna
country: Austria
facility: CARITAS Rundum zu Hause betreut
city: Vienna
country: Austria
facility: ipb - Institut für Personenbetreuung
city: Vienna
country: Austria
facility: Johanniter Österreich Ausbildung und Forschung gem. GmbH
Study officials:
affiliation: FH Campus Wien, University of Applied Sciences
name: Elisabeth Haslinger-Bauman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: FH Campus Wien, University of Applied Sciences
name: Franz Werner, PhD
role: STUDY_DIRECTOR
References: