Clinical trial NCT06199648: Digital Solutions for Elderly Care by Informal Caregivers
Official title: Digital Solutions for Elderly Care by Informal Caregivers: A Study on Nursing Benefits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Activities of Daily Living
Keywords: Caregivers*
Frail Elderly*
Humans
Austria
Telemedicine
Lead sponsor: University of Applied Sciences for Health Professions Upper Austria
Sponsor class: OTHER
Collaborators: name: LICA Life Care GmbH
First posted: 2024-01-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to determine the benefits of a web-based documentation and advice for elderly people and their caregivers. It is a randomized controlled trial with two arms (intervention, control). While the participants will be supported by a web-based application within the intervention, they will receive standard care only in the control. In addition, a follow-up until the end of the study will be realized.

Detailed description: Background: The majority of elderly people want to live at home, and the home care they need is often provided by informal caregivers. In addition, the number of elderly people is increasing while the number of people who can support them is decreasing. It is therefore important to improve the quality of care and support caregivers. Unfortunately, caregivers are often under heavy strain and the amount of time they can spend receiving advice and support is very limited. Web-based applications could be a solution to address the time needs of caregivers, but little is known about whether such applications are of benefit to the elderly themselves or their caregivers.

Description of the Intervention: A web-based documentation and advice application for home care for elderly people. The intervention is based on the daily status diary, the completion of daily tasks, the writing of short reports (if applicable) and the documentation of the caregiver's constitution. Adherence to the purpose of the web-based application is defined as entering data at least 5 out of 7 days per week.

It is a single-center, open-label, randomized controlled trial with two arms (intervention, control). The study consists of one in person screening visit, two in person study visits and 3 monthly follow-up visits via phone (Visit 0: Screening Visit, Visit 1: Baseline Visit, Visit 2: End of Study Visit, Visit 3: Follow-up). The study-related measurements are: Barthel Index, Short Form of the Late Life Function and Disability Instrument, 5-level EuroQol quality of life questionnaire (EQ-5D-5L), De Morton Mobility Index (DEMMI), individual's general self-efficacy (GSE), user experience questionnaire short form (UEQ-S), Adherence (minimum frequency with which the daily diary was completed by the caregiver). The study begins when both parties in the pair (elderly person and caregiver) sign the informed consent form and ends when the older person dies or the study ends, whichever comes first. The intervention period is 12 weeks.

Eligibility criteria: Key Inclusion Criteria for the Elderly Person:

* 55 years and older
* Community-dwelling
* Resident in Upper Austria
* Barthel Index below 100
* Requires assistance with activities of daily living

Key Exclusion Criteria for the Elderly Person:

* Planned nursing home admission in the next 12 weeks
* Chronic obstructive pulmonary disease stage III or IV
* Insufficient understanding and judgment to consent to the study

Main Inclusion Criteria for the Caregiver:

* Caregiver of an older person
* Tech savvy
* Committed to using an app to support caregiving

Main Exclusion Criteria for the Caregiver:

* 17 years and younger
* Insufficient insight and judgment to consent to the study

Primary outcomes:
measure: Mean change in function and disability of the elderly participant estimated with Barthel Index (BI)
timeFrame: 104 Weeks
Secondary outcomes:
measure: Mean change in function and disability of the elderly participant estimated with Short Form of the Late-Life Function and Disability Instrument (SF-LLFDI)
timeFrame: 104 Weeks
measure: Mean change in quality of life of the elderly participant estimated using the 5-item and 5-dimension versions of the EuroQoL questionnaire (EQ-5D-5L)
timeFrame: 104 Weeks
measure: Mean change in mobility of the elderly participant estimated with the de Morton Mobility Index (DEMMI)
timeFrame: 104 Weeks
measure: Mean change in self-efficacy of the elderly participant estimated using the General Self-Efficacy Short Scale (GSE)
timeFrame: 104 Weeks
measure: Mean change in quality of life of the caregiver estimated with EQ-5D-5L
timeFrame: 104 Weeks
measure: User experience estimated with the UEQ-S
timeFrame: 1 Hour
measure: Change in status of the caregiver over time estimated with the daily caregiver status diary
timeFrame: 12 Weeks
measure: Adherence by days with no entry in the daily status diary
timeFrame: 12 Weeks
measure: Survival of the elderly participant based on the number of Grade 5 adverse events in the elderly participant estimated using an adverse event (AE) reporting form.
timeFrame: 104 Weeks
measure: Hospitalization rate, with the number of adverse events requiring hospitalization of the elderly participant estimated using an adverse event (AE) reporting form.
timeFrame: 104 Weeks
measure: Safety, with number of adverse events estimated using an adverse event (AE) reporting form.
timeFrame: 104 Weeks
Other outcomes:
Locations:
city: Linz
country: Austria
facility: University of Applied Sciences for Health Professions Upper Austria
state: Upper Austria
Study officials:
affiliation: Institute of Physical Medicine and Rehabilitation, Kepler University Hospital, Linz, Austria
name: Christian Mittermaier, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Applied Sciences for Health Professions Upper Austria
name: Bernhard Schwartz, Dr. BSc MSc
role: STUDY_DIRECTOR
References: