NCT06199648

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 29, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

November 21, 2023

Last Update Submit

May 27, 2024

Conditions

Activities of Daily Living

Keywords

Caregivers*Frail Elderly*HumansAustriaTelemedicine

Outcome Measures

Primary Outcomes (1)

  • Mean change in function and disability of the elderly participant estimated with Barthel Index (BI)

    The BI assesses the functional status and independence in basic activities of daily living (ADL) of elderly people. Each domain is scored on a 0-5 or 0-10 scale, with the overall score ranging from 0 to 100. A higher score represents a higher level of independence. The BI will be rated by the study staff. The Hamburg Classification Manual provides detailed criteria for scoring.

    104 Weeks

Secondary Outcomes (11)

  • Mean change in function and disability of the elderly participant estimated with Short Form of the Late-Life Function and Disability Instrument (SF-LLFDI)

    104 Weeks

  • 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)

    104 Weeks

  • Mean change in mobility of the elderly participant estimated with the de Morton Mobility Index (DEMMI)

    104 Weeks

  • Mean change in self-efficacy of the elderly participant estimated using the General Self-Efficacy Short Scale (GSE)

    104 Weeks

  • Mean change in quality of life of the caregiver estimated with EQ-5D-5L

    104 Weeks

  • +6 more secondary outcomes

Study Arms (2)

Arm A: web-based documentation and advice

EXPERIMENTAL
Other: web-based documentation and advice

Arm B: Standard of care

NO INTERVENTION

Interventions

web-based documentation and adviceOTHER

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

Arm A: web-based documentation and advice

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Caregiver of an older person
  • Tech savvy
  • Committed to using an app to support caregiving
  • years and younger
  • Insufficient insight and judgment to consent to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Applied Sciences for Health Professions Upper Austria

Linz, Upper Austria, 4020, Austria

RECRUITING

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Christian Mittermaier, Dr.

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

    PRINCIPAL INVESTIGATOR

  • Bernhard Schwartz, Dr. BSc MSc

    University of Applied Sciences for Health Professions Upper Austria

    STUDY DIRECTOR

Central Study Contacts

Sebastian Rosendahl Huber, BScN MScN

CONTACT

+43 50344Sebastian.Rosendahl-Huber@fhgooe.ac.at

Ursula Halbmayr-Kubicsek, Mag. Dr. MSc

CONTACT

+43 50344ursula.halbmayr-kubicsek@fhgooe.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Only pseudonymous, blinded data will be provided to statisticians for analysis.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2023

First Posted

January 10, 2024

Study Start

January 8, 2024

Primary Completion

December 30, 2024

Study Completion

March 1, 2025

Last Updated

May 29, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)