Care GiversA0004NCT06741462
Positive Care Effect of the Digital Health Assistant ADELE for Patients with Care Level
A study testing Digital health assistant ADELE A0004 in people with Care Givers and Health, run by Alma Phil Gmbh at 2 sites in Germany.
Trial summary
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to cope with everyday life due to health impairments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care Givers, Health, Care of the Elderly
- What is being tested?
- Digital health assistant ADELE A0004
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Oct 2022to 16 Dec 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consent to participate in the study
- Age (at least 18 years)
- Level of care I-V: People in need of care with impaired cognitive abilities; People in need of care with impaired ability to structure their day and/or impaired ability to remember; People in need of care with impaired ability to orient themselves in time; Risk of falls in the normal everyday environment
- Person must be able to understand the patient information
- Written declaration of consent is signed at the beginning of interview 1
Who cannot join
- Age under 18 years
- Persons belonging to specially protected groups (e.g. persons temporarily or permanently unable to give consent)
- Person suffers from mental illness that prevents them from understanding the information about the study, giving their consent or complying with the requirements of the study
- Person is unable to operate the application properly
- Person has already had contact with the application and/or a comparable application
- Person is participating in another study
- Emergency and intensive care medicine
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Johanniter-Unfall-Hilfe e.V.
Hanover, Lower Saxony, 30624
Ökumenische Sozialstation Heidenheimer Land
Heidenheim, Baden-Wurttemberg, 89520
About this study
Official title: Prospective Randomized Study to Prove a Positive Care Effect of the Digital Health Assistant ADELE A0004 for Patients with a Care Level
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to cope with everyday life due to health impairments. The risk of needing care increases with age. ALMA PHIL has set itself the goal of using the digital health assistant ADELE A0004 (ADELE for short) to make everyday life easier for people in need of care, thereby maintaining their independence and preventing any deterioration in their need for care.
The study aims to prove the positive care benefits of using ADELE for people with a care level on e.g., the improvement and stabilization of independence especially in the home care situation; reducing the mental and physical strain of coping with the need for care in everyday life; improving the mobility of the person in need of care; maintaining cognitive and communicative abilities and on the improvement of adherence. In addition, the nursing benefits of ADELE also include relieving the daily burden on the personal care network.
Read the detailed description
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to cope with everyday life due to health impairments. The risk of needing care increases with age. While around 9% of people aged 70 to 74 living in Germany are in need of care, the proportion for those aged 90 and over is around 82%. The forecasts of the Federal Statistical Office also show a growing number of people with a care level in the coming years and an associated increase in the need for care. Around four out of five people in need of care are nursed at home, mostly by relatives.
ALMA PHIL has set itself the goal of using the digital health assistant ADELE A0004 (ADELE for short) to make everyday life easier for people in need of care, thereby maintaining their independence and preventing any deterioration in their need for care.
This study aims to prove the positive care benefits of using ADELE for people with a care level. The increase in knowledge from the study consists in the positive effectiveness and the nursing benefits for people in need of care, e.g., on the improvement and stabilization of independence especially in the home care situation; on reducing the mental and physical strain of coping with the need for care in everyday life; on improving the mobility of the person in need of care; on maintaining cognitive and communicative abilities (independence and social interaction) and on the improvement of adherence (regular intake of medication, regular fulfillment of set goals). In addition, the nursing benefits of ADELE also include relieving the daily burden on the personal care network.
A prospective randomized multicenter study with a parallel group design was used. To conduct the study, adult participants with proven care level were randomly assigned to the intervention group or the control group as part of a 1:1 randomization. The observation period per participant was 3 months on average. The data was collected by means of questionnaires. ADELE was provided to the intervention group. ADELE was not provided to the participants in the control group.
The primary objective of the study was to prove the improvement in patient sovereignty from the perspective of the patient with a care level, measured after 3 months. As secondary endpoints were defined (all measured after 3 months): the improvement of mobility, the improvement of mental and physical health, the improvement in patient sovereignty from the perspective of the caregiver, the reducing of the burden on the caregiver of the person in need of care in everyday life through the digital care application. As additional exploratory endpoints were the improvement in health confidence and the reduction of the systolic and diastolic blood pressure values defined, measured after 3 months.
- Being tested
- Digital health assistant ADELE A0004
- Keywords
- digital health, health assistant, Patient autonomy, care level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital health assistant ADELE A0004Device
The digital health assistant ADELE A0004 (ADELE for short) improves the daily lives of patients with care level and enables them to deal better and more independently with the everyday burdens resulting from the need for care. Participants in the intervention group were provided with ADELE to use during the study period for e.g., tracking of daily reminders, voice-based recording, interpretation and classification of their vital signs and body conditions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | Participants in the intervention group were patients with proven care level who had been provided ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were gathered using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). Receives: Device: Digital health assistant ADELE A0004 |
| Control Group | No intervention | Participants in the control group were patients with proven care level who were not provided with ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were collected using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). In addition, after the end of the observation period (from t0 to t1), the participants in the control group were offered an extension of a further 3 months on average using ADELE (from t1 to t2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of patient autonomy
Change of patient autonomy, defined as the stabilization of autonomous coping with burdens in everyday life from the perspective of the patient with a care level, measured after 3 months based on PS19 score. The PS19 questionnaire had 19 items. The score is between 0 (Minimum) and 57 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (6)
Change in mobility of patient
Evaluation of the 6-minute walk test (short 6MWT) to assess the performance of the patient with a care level and to be able to monitor it over time. A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Change of patient autonomy
Change of patient autonomy, defined as the stabilization of autonomous coping with burdens in everyday life from the perspective of the patient with a care level, measured after 3 months based on PS8D score. The PS8D questionnaire had 8 items. The score is between 0 (Minimum) and 24 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Change of patient autonomy (caregiver perpective)
Change of autonomy of patient with care level, defined as the stabilization of autonomous coping with burdens in everyday life from the perspective of the caregiver, measured after 3 months based on PS8D-P score. The PS8D-P questionnaire had 8 items. The score is between 0 (Minimum) and 24 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Change of patient autonomy (caregiver perpective)
Change of autonomy of patient with care level, defined as the stabilization of autonomous coping with burdens in everyday life from the perspective of the caregiver, measured after 3 months based on PS19-P score. The PS19-P questionnaire had 19 items. The score is between 0 (Minimum) and 57 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Change of Reliefe for caregiver
Relieving the caregiver of the person in need of care in everyday life through the digital care application, measured after 3 months based on the ICG score. The ICG questionnaire had 6 items. The score is between 0 (Minimum) and 18 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Change of health condition
Change of health condition, measured after 3 months using Short Form 12 Health Survey (SF-12). The scale is based on 12 items. The score is between 0 (Minimum) and 100 (Maximum). A higher value is better.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start7 Oct 2022
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care GiversStudies 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
- Model description
- Intervention group: Participants in the intervention group were patients with proven care level who had been provided ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were gathered using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). Control group: Participants in the control group were patients with proven care level who were not provided with ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were collected using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). In addition, after the end of the observation period (from t0 to t1), the participants in the control group were offered an extension of a further 3 months on average using ADELE (from t1 to t2).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Phil Gmbh
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Hoffmann, Prof. Dr. med., Study chair, (Minority) shareholderOliver Vonend, Prof. Dr. med., Principal investigatorHans-Peter Reiffen, Prof. Dr. med., Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741462
- Sponsor's protocol ID
- APH01_PG
- Acronym
- A0004
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Prove a Positive Care Effect of the Digital Health Assistant ADELE A0004 for Patients with a Care Level
- ClinicalTrials.gov ID
- NCT06741462
- Acronym / sponsor ID
- A0004 / APH01_PG
- Keywords
- digital health, health assistant, Patient autonomy, care level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Alma Phil GmbhIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 19 Dec 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.
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to cope with everyday life due to health impairments. The risk of needing care increases with age. ALMA PHIL has set itself the goal of using the digital health assistant ADELE A0004 (ADELE for short) to make everyday life easier for people in need of care, thereby maintaining their independence and preventing any deterioration in their need for care.
The study aims to prove the positive care benefits of using ADELE for people with a care level on e.g., the improvement and stabilization of independence especially in the home care situation; reducing the mental and physical strain of coping with the need for care in everyday life; improving the mobility of the person in need of care; maintaining cognitive and communicative abilities and on the improvement of adherence. In addition, the nursing benefits of ADELE also include relieving the daily burden on the personal care network.
Detailed description
Care is becoming an increasingly important topic in Germany due to the rising number of people in need of care. There are currently around 5 million people with a care level in Germany who are permanently dependent on help to cope with everyday life due to health impairments. The risk of needing care increases with age. While around 9% of people aged 70 to 74 living in Germany are in need of care, the proportion for those aged 90 and over is around 82%. The forecasts of the Federal Statistical Office also show a growing number of people with a care level in the coming years and an associated increase in the need for care. Around four out of five people in need of care are nursed at home, mostly by relatives.
ALMA PHIL has set itself the goal of using the digital health assistant ADELE A0004 (ADELE for short) to make everyday life easier for people in need of care, thereby maintaining their independence and preventing any deterioration in their need for care.
This study aims to prove the positive care benefits of using ADELE for people with a care level. The increase in knowledge from the study consists in the positive effectiveness and the nursing benefits for people in need of care, e.g., on the improvement and stabilization of independence especially in the home care situation; on reducing the mental and physical strain of coping with the need for care in everyday life; on improving the mobility of the person in need of care; on maintaining cognitive and communicative abilities (independence and social interaction) and on the improvement of adherence (regular intake of medication, regular fulfillment of set goals). In addition, the nursing benefits of ADELE also include relieving the daily burden on the personal care network.
A prospective randomized multicenter study with a parallel group design was used. To conduct the study, adult participants with proven care level were randomly assigned to the intervention group or the control group as part of a 1:1 randomization. The observation period per participant was 3 months on average. The data was collected by means of questionnaires. ADELE was provided to the intervention group. ADELE was not provided to the participants in the control group.
The primary objective of the study was to prove the improvement in patient sovereignty from the perspective of the patient with a care level, measured after 3 months. As secondary endpoints were defined (all measured after 3 months): the improvement of mobility, the improvement of mental and physical health, the improvement in patient sovereignty from the perspective of the caregiver, the reducing of the burden on the caregiver of the person in need of care in everyday life through the digital care application. As additional exploratory endpoints were the improvement in health confidence and the reduction of the systolic and diastolic blood pressure values defined, measured after 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention group: Participants in the intervention group were patients with proven care level who had been provided ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were gathered using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). Control group: Participants in the control group were patients with proven care level who were not provided with ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were collected using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). In addition, after the end of the observation period (from t0 to t1), the participants in the control group were offered an extension of a further 3 months on average using ADELE (from t1 to t2).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Digital health assistant ADELE A0004Participants in the intervention group were patients with proven care level who had been provided ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were gathered using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). |
| Control Group | No intervention | –Participants in the control group were patients with proven care level who were not provided with ADELE for the duration of the study. The observation period per participant was 3 months on average. Data on the primary, secondary and exploratory endpoints were collected using questionnaires at study inclusion (t0) and an average of 3 months after randomization (t1). In addition, after the end of the observation period (from t0 to t1), the participants in the control group were offered an extension of a further 3 months on average using ADELE (from t1 to t2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Consent to participate in the study
- Age (at least 18 years)
- Level of care I-V: People in need of care with impaired cognitive abilities; People in need of care with impaired ability to structure their day and/or impaired ability to remember; People in need of care with impaired ability to orient themselves in time; Risk of falls in the normal everyday environment
- Person must be able to understand the patient information
- Written declaration of consent is signed at the beginning of interview 1
Key exclusion criteria (7 listed)
- Age under 18 years
- Persons belonging to specially protected groups (e.g. persons temporarily or permanently unable to give consent)
- Person suffers from mental illness that prevents them from understanding the information about the study, giving their consent or complying with the requirements of the study
- Person is unable to operate the application properly
- Person has already had contact with the application and/or a comparable application
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 |
|---|---|---|
| Digital health assistant ADELE A0004The digital health assistant ADELE A0004 (ADELE for short) improves the daily lives of patients with care level and enables them to deal better and more independently with the everyday burdens resulting from the need for care. Participants in the intervention group were provided with ADELE to use during the study period for e.g., tracking of daily reminders, voice-based recording, interpretation and classification of their vital signs and body conditions. | Device | Intervention Group |
Primary outcome
Change of patient autonomy
Time frame: From enrollment to the end of treatment at 3 months
Change of patient autonomy, defined as the stabilization of autonomous coping with burdens in everyday life from the perspective of the patient with a care level, measured after 3 months based on PS19 score. The PS19 questionnaire had 19 items. The score is between 0 (Minimum) and 57 (Maximum). A higher value is better.
6 secondary outcomes
Change in mobility of patient
Time frame: From enrollment to the end of treatment at 3 months
Change of patient autonomy
Time frame: From enrollment to the end of treatment at 3 months
Change of patient autonomy (caregiver perpective)
Time frame: From enrollment to the end of treatment at 3 months
Change of patient autonomy (caregiver perpective)
Time frame: From enrollment to the end of treatment at 3 months
Change of Reliefe for caregiver
Time frame: From enrollment to the end of treatment at 3 months
Change of health condition
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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.
Thomas Hoffmann, Prof. Dr. med. study chair
(Minority) shareholder
Oliver Vonend, Prof. Dr. med. principal investigator
Hans-Peter Reiffen, Prof. Dr. med. study director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital health assistant ADELE A0004 in people with Care Givers and Health, run by Alma Phil Gmbh at 2 sites in Germany.
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 7 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: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of patient autonomy (time frame: From enrollment to the end of treatment at 3 months). 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 19 Dec 2024.