Digital Solutions for Elderly Care by Informal Caregivers

NCT ID: NCT06199648

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-03-01

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.

Conditions

Activities of Daily Living

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm A: web-based documentation and advice

Group Type: EXPERIMENTAL

web-based documentation and advice

Intervention Type: OTHER

Caregivers will be supported with a web-based documentation and advice system for home care for elderly people

Arm B: Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

web-based documentation and advice

Caregivers will be supported with a web-based documentation and advice system for home care for elderly people

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LICA Life Care GmbH

UNKNOWN

Sponsor Role: collaborator

University of Applied Sciences for Health Professions Upper Austria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Mittermaier, Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Physical Medicine and Rehabilitation, Kepler University Hospital, Linz, Austria

Bernhard Schwartz, Dr. BSc MSc

Role: STUDY_DIRECTOR

University of Applied Sciences for Health Professions Upper Austria

Locations

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Sebastian Rosendahl Huber, BScN MScN

Role: CONTACT

Sebastian.Rosendahl-Huber@fhgooe.ac.at

+43 50344 ext. 20034

Ursula Halbmayr-Kubicsek, Mag. Dr. MSc

Role: CONTACT

ursula.halbmayr-kubicsek@fhgooe.ac.at

+43 50344 ext. 42121

Facility Contacts

Sebastian Rosendahl-Huber, MScN

Role: primary

Sebastian.Rosendahl-Huber@fhgooe.ac.at

+435034420034

Other Identifiers

DigiSecc 001

Identifier Type: -

Identifier Source: org_study_id