Clinical trial NCT06741462: Positive Care Effect of the Digital Health Assistant ADELE for Patients with Care Level
Official title: Prospective Randomized Study to Prove a Positive Care Effect of the Digital Health Assistant ADELE A0004 for Patients with a Care Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Care Givers
Health
Care of the Elderly
Health Care Delivery
Mobility and Independence
Keywords: digital health
health assistant
Patient autonomy
care level
Lead sponsor: Alma Phil Gmbh
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of patient autonomy
timeFrame: From enrollment to the end of treatment at 3 months
Secondary outcomes:
measure: Change in mobility of patient
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of patient autonomy
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of patient autonomy (caregiver perpective)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of patient autonomy (caregiver perpective)
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of Reliefe for caregiver
timeFrame: From enrollment to the end of treatment at 3 months
measure: Change of health condition
timeFrame: From enrollment to the end of treatment at 3 months
Other outcomes:
Locations:
city: Heidenheim
country: Germany
facility: Ökumenische Sozialstation Heidenheimer Land
state: Baden-Wuerttemberg
city: Hannover
country: Germany
facility: Johanniter-Unfall-Hilfe e.V.
state: Niedersachsen
Study officials:
affiliation: (Minority) shareholder
name: Thomas Hoffmann, Prof. Dr. med.
role: STUDY_CHAIR
name: Oliver Vonend, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
name: Hans-Peter Reiffen, Prof. Dr. med.
role: STUDY_DIRECTOR
References: