Digital Solutions for Elderly Care by Informal Caregivers (DigiSECC)

University of Applied Sciences for Health Professions Upper Austria

Status: Enrolling

Conditions: Activities of Daily Living

Treatments: Other: web-based documentation and advice

Study type: Interventional

Funder types: Other

Identifiers

NCT06199648

DigiSecc 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Arm A: web-based documentation and advice

Experimental group

Treatment:

Other: web-based documentation and advice

Arm B: Standard of care

No Intervention group