Activities of Daily LivingDigiSECCNCT06199648
Digital Solutions for Elderly Care by Informal Caregivers
A study testing web-based documentation and advice in people with Activities of Daily Living, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Activities of Daily Living
- What is being tested?
- web-based documentation and advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteAustria
- Study dates
- 8 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 55 years and older
- Community-dwelling
- Resident in Upper Austria
- Barthel Index below 100
- Requires assistance with activities of daily living
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Sebastian Rosendahl Huber, BScN MScN contact
Ursula Halbmayr-Kubicsek, Mag. Dr. MSc contact
Austria1 site, 1 recruiting
- Recruiting
University of Applied Sciences for Health Professions Upper Austria
Linz, Upper Austria, 4020
Sebastian Rosendahl-Huber, MScN, +435034420034, Sebastian.Rosendahl-Huber@fhgooe.ac.at
About this study
Official title: Digital Solutions for Elderly Care by Informal Caregivers: A Study on Nursing Benefits
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.
Read the 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
- Being tested
- web-based documentation and advice
- Keywords
- Caregivers*, Frail Elderly*, Humans, Austria, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based documentation and adviceOther
Caregivers will be supported with a web-based documentation and advice system for home care for elderly people
| Study group | Role | What they receive |
|---|---|---|
| Arm A: web-based documentation and advice | Experimental | Not described Receives: Other: web-based documentation and advice |
| Arm B: Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 104 Weeks
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.
Measured: 104 Weeks
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.
Measured: 104 Weeks
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.
Measured: 104 Weeks
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.
Measured: 1 Hour
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.
Measured: 12 Weeks
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%).
Measured: 12 Weeks
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.
Measured: 104 Weeks
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.
Measured: 104 Weeks
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.
Measured: 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start8 Jan 2024
- Primary completion30 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences for Health Professions Upper Austria
- Sponsor type
- University, hospital or other
- Collaborators
- LICA Life Care GmbH
- Responsible party
- Sponsor
- Investigators
- Christian Mittermaier, Dr., Principal investigator, Institute of Physical Medicine and Rehabilitation, Kepler University Hospital, Linz, AustriaBernhard Schwartz, Dr. BSc MSc, Study director, University of Applied Sciences for Health Professions Upper Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06199648
- Sponsor's protocol ID
- DigiSecc 001
- Acronym
- DigiSECC
- Status last verified
- May 2024
- First submitted
- 21 Nov 2023
- Last updated
- 29 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Solutions for Elderly Care by Informal Caregivers: A Study on Nursing Benefits
- ClinicalTrials.gov ID
- NCT06199648
- Acronym / sponsor ID
- DigiSECC / DigiSecc 001
- Conditions
- Activities of Daily Living
- Keywords
- Caregivers*, Frail Elderly*, Humans, Austria, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Applied Sciences for Health Professions Upper AustriaUniversity, hospital or other
- Collaborators
- LICA Life Care GmbH
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: web-based documentation and advice | Experimental | Other: web-based documentation and advice |
| Arm B: Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 55 years and older
- Community-dwelling
- Resident in Upper Austria
- Barthel Index below 100
- Requires assistance with activities of daily living
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based documentation and adviceCaregivers will be supported with a web-based documentation and advice system for home care for elderly people | Other | Arm A: web-based documentation and advice |
Primary outcome
Mean change in function and disability of the elderly participant estimated with Barthel Index (BI)
Time frame: 104 Weeks
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.
11 secondary outcomes
Mean change in function and disability of the elderly participant estimated with Short Form of the Late-Life Function and Disability Instrument (SF-LLFDI)
Time frame: 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)
Time frame: 104 Weeks
Mean change in mobility of the elderly participant estimated with the de Morton Mobility Index (DEMMI)
Time frame: 104 Weeks
Mean change in self-efficacy of the elderly participant estimated using the General Self-Efficacy Short Scale (GSE)
Time frame: 104 Weeks
Mean change in quality of life of the caregiver estimated with EQ-5D-5L
Time frame: 104 Weeks
User experience estimated with the UEQ-S
Time frame: 1 Hour
Change in status of the caregiver over time estimated with the daily caregiver status diary
Time frame: 12 Weeks
Adherence by days with no entry in the daily status diary
Time frame: 12 Weeks
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.
Time frame: 104 Weeks
Hospitalization rate, with the number of adverse events requiring hospitalization of the elderly participant estimated using an adverse event (AE) reporting form.
Time frame: 104 Weeks
Safety, with number of adverse events estimated using an adverse event (AE) reporting form.
Time frame: 104 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Rosendahl Huber, BScN MScN contact
Ursula Halbmayr-Kubicsek, Mag. Dr. MSc contact
Christian Mittermaier, Dr. principal investigator
Institute of Physical Medicine and Rehabilitation, Kepler University Hospital, Linz, Austria
Bernhard Schwartz, Dr. BSc MSc study director
University of Applied Sciences for Health Professions Upper Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based documentation and advice in people with Activities of Daily Living, run by University of Applied Sciences for Health Professions Upper Austria at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Rosendahl Huber, BScN MScN (+43 50344 ext. 20034, Sebastian.Rosendahl-Huber@fhgooe.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in function and disability of the elderly participant estimated with Barthel Index (BI) (time frame: 104 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.