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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04581538
Other study ID # AAL01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date October 31, 2021

Study information

Verified date March 2022
Source FH Campus Wien, University of Applied Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


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).


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intervention of parallel arm 2
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 3
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.

Locations

Country Name City State
Austria Home-Care-Management ALEXANDER WINTER e.U. Breitstetten
Austria CARITAS Rundum zu Hause betreut Vienna
Austria ipb - Institut für Personenbetreuung Vienna
Austria Johanniter Österreich Ausbildung und Forschung gem. GmbH Vienna

Sponsors (7)

Lead Sponsor Collaborator
Peter Putz CARITAS Rundum zu Hause betreut, Home-Care-Management ALEXANDER WINTER e.U., ipb - Institut für Personenbetreuung, Johanniter Österreich Ausbildung und Forschung gem. GmbH, NOUS Wissensmanagement GmbH, Österreichischer Gesundheits- und Krankenpflegeverband

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Other Self-perceived health of Care Receivers as specified by the European Core Health Indicators (ECHI short list) Ordinal scale. The question on self-perceived health ('How is your health in general?') refers to the respondent's own assessment of his or her health, which contains five answering categories: 1) very good, 2) good, 3) fair, 4) bad, 5) very bad. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Other Frequency of change of Caregivers Baseline, 3 Month Follow-Up, 12 Month Follow-Up Metric scale. Annualized rate, recorded by investigator.
Other Geriatric Depression Scale (GDS) Geriatric Depression Scale (GDS) of Care Receivers Metric scale. Standardized metric score ranging from 0 to 15, where higher scores mean a better outcome. Care receivers' GDS short form (Sheikh and Yesavage 1986). 15 questions, interviewed by investigator. Each check corresponds to one score point with a maximum count of 15. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Primary 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
Primary 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
Primary 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 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. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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. Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
Secondary 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 Baseline, 3 Month Follow-Up, 12 Month Follow-Up
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