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 |
|
