Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06199648
Other study ID # DigiSecc 001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 8, 2024
Est. completion date March 1, 2025

Study information

Verified date May 2024
Source University of Applied Sciences for Health Professions Upper Austria
Contact Sebastian Rosendahl Huber, BScN MScN
Phone +43 50344
Email Sebastian.Rosendahl-Huber@fhgooe.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 132
Est. completion date March 1, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Austria University of Applied Sciences for Health Professions Upper Austria Linz Upper Austria

Sponsors (2)

Lead Sponsor Collaborator
University of Applied Sciences for Health Professions Upper Austria LICA Life Care GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mean change in function and disability of the elderly participant estimated with Short Form of the Late-Life Function and Disability Instrument (SF-LLFDI) The SF-LLFDI assesses two domains: function and disability, with various subdomains. It is a self-administered questionnaire that can be completed online or on paper, consisting of 32 items rated on a 5-point Likert scale. The scores are converted into a percentage of the maximum possible score for each subdomain and domain, with higher scores indicating better function or less disability. The SF-LLFDI will be self-rated by the elderly participant. 104 Weeks
Secondary 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) The EQ-5D-5L is a patient-reported outcome measure that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health status by ticking the box next to the most appropriate statement in each of the five dimensions. This results in a 5-digit number describing the patient's health. The EQ-5D-5L is self-reported by the elderly participant. 104 Weeks
Secondary Mean change in mobility of the elderly participant estimated with the de Morton Mobility Index (DEMMI) The DEMMI is an advanced instrument designed to measure and monitor changes in mobility for older adults. It assesses tasks ranging from bed/bedside to dynamic balance and increases in difficulty. Each task is scored in each category 0, 1, or 2. The raw score maximum total is 19, and the converted score maximum total is 100. The DEMMI will be rated by a health professional. 104 Weeks
Secondary Mean change in self-efficacy of the elderly participant estimated using the General Self-Efficacy Short Scale (GSE) The GSE measures general self-efficacy, which describes an individual's overall confidence in their own competence. It consists of ten items scored on a 4-point Likert-type scale. The total score ranges from 10 to 40, with higher scores indicating higher levels of general self-efficacy. The GSE is self-reported by the elderly participant. 104 Weeks
Secondary Mean change in quality of life of the caregiver estimated with EQ-5D-5L The EQ-5D-5L is a patient-reported outcome measure that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his or her health status by ticking the box next to the most appropriate statement in each of the five dimensions. This results in a 5-digit number describing the patient's health. The EQ-5D-5L is self-reported by the caregiver. 104 Weeks
Secondary User experience estimated with the UEQ-S The UEQ-S measures the overall attractiveness of the web-based application in two domains of user experience: pragmatic quality and hedonic quality. Pragmatic quality refers to the usability, efficiency and clarity of the web-based application, while hedonic quality refers to the stimulation, interest and novelty of the web-based application. The UEQ-S is rated by the caregiver. 1 Hour
Secondary Change in status of the caregiver over time estimated with the daily caregiver status diary Caregivers rate their experience, effort and positive moments on a daily smiley scale of 1 to 5, with more smileys indicating a better rating. The data is exported for analysis and is also used to record adverse events related to the elderly person. 12 Weeks
Secondary Adherence by days with no entry in the daily status diary Adherence is defined as the degree to which an individual uses an eHealth technology in accordance with the manufacturer's recommendations. In this study, adherence to the use of the application is assessed by examining the data entered by the caregiver into the daily status diary and the days with no entries. Adherence is defined as making entries on at least 5 days within a week in 9 out of 12 weeks (i.e. 75%). 12 Weeks
Secondary 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. Survival based on the number of Grade 5 adverse events experienced by the older participant, as recorded on an AE reporting form. A higher number of grade 5 adverse events indicates a lower survival rate. 104 Weeks
Secondary Hospitalization rate, with the number of adverse events requiring hospitalization of the elderly participant estimated using an adverse event (AE) reporting form. The hospitalization rate is determined based on the number of adverse events requiring hospitalization experienced by the older participant, as recorded on an AE reporting form. A higher number of AEs reporting hospitalization indicates a higher hospitalization rate. 104 Weeks
Secondary Safety, with number of adverse events estimated using an adverse event (AE) reporting form. Safety is determined by the number of adverse events experienced by the elderly participant and recorded on an AE reporting form. A higher number of adverse events indicates a lower level of safety. 104 Weeks
See also
  Status Clinical Trial Phase
Completed NCT04399759 - Instrumental Activities of Daily Living Approach in Home Environment for Patients With Stroke N/A
Completed NCT04774562 - The Effect of Video-Assisted Discharge Education After Total Hip Replacement Surgery N/A
Completed NCT03335709 - A Better Everyday Life 1.0 - a Protocol for a Feasibility Study N/A
Completed NCT02890927 - Geriatric-CO-mAnagement for Cardiology Patients in the Hospital N/A
Recruiting NCT04891471 - WHOle Brain Irradiation or STEreotactic Radiosurgery for Five or More Brain Metastases (WHOBI-STER) N/A
Completed NCT05529732 - The Effect of Mobile Education on Anxiety and Activities of Daily Living N/A
Enrolling by invitation NCT05411393 - Synergizing Home Health Rehabilitation Therapy N/A
Completed NCT04026061 - Pilot Study Person-centred Tablet Intervention N/A
Completed NCT03209310 - The Effect of Trunk Control on Respiratory Muscle Strength N/A
Completed NCT01459939 - A Double-blind, Randomized, Parallel Group, Fase III Comparative Study With Rose Hip Powder Powder and Placebo Given to Patients With Mild to Moderate Osteoarthritis in the Knee or/and Hip Phase 3
Completed NCT01216722 - Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant N/A
Recruiting NCT06410014 - Assessment of Overall Functioning in Patients With Complex Health Issues
Recruiting NCT05773560 - Virtual Reality in the Rehabilitation in Patients With Lower Limb Amputation. N/A
Not yet recruiting NCT03333798 - Psychosocial Intervention With Community Worker Support for Survivors of Intimate Partner Violence N/A
Completed NCT00912600 - Intensive Care Unit (ICU) Admission Decisions in the Elderly : the ICE-CUB Study N/A
Completed NCT00888953 - Nursing Homes Study of Fall Risk Assessment Oriented to Intervention N/A
Completed NCT03440203 - Prevalence of Peripheral Neuropathy and Its Impact on Activities of Daily Living in Patients With Type 2 Diabetes
Recruiting NCT06226285 - Quality of Life for Carers Through a Person-Centred Technological Solution N/A
Recruiting NCT03106064 - Independence in Self Care - A Program Focused on Nursing Care N/A
Completed NCT04655547 - Impact on Energy Intake by Implementing Recommended Food Texture Through Dietary Guidance N/A