Positive Care Effect of the Digital Health Assistant ADELE for Patients with Care Level

NCT06741462 | Completed

• 1 other identifier: APH01_PG
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Care Givers; Health; Care of the Elderly; Health Care Delivery; Mobility and Independence

Keywords

digital health; health assistant; Patient autonomy; care level

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (6)

• Change in mobility of patient

  From enrollment to the end of treatment at 3 months

• Change of patient autonomy

  From enrollment to the end of treatment at 3 months

• Change of patient autonomy (caregiver perpective)

  From enrollment to the end of treatment at 3 months

• Change of patient autonomy (caregiver perpective)

  From enrollment to the end of treatment at 3 months

• Change of Reliefe for caregiver

  From enrollment to the end of treatment at 3 months

Study Arms (2)

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).

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).

Interventions

Digital health assistant ADELE A0004 DEVICE

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alma Phil Gmbh: lead

Study Sites (2)

Ökumenische Sozialstation Heidenheimer Land

Heidenheim, Baden-Wurttemberg, 89520, Germany

Location

Johanniter-Unfall-Hilfe e.V.

Hanover, Lower Saxony, 30624, Germany

Location

Study Officials

• Thomas Hoffmann, Prof. Dr. med.

  (Minority) shareholder

  STUDY CHAIR

• Oliver Vonend, Prof. Dr. med.

  PRINCIPAL INVESTIGATOR

• Hans-Peter Reiffen, Prof. Dr. med.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: October 7, 2022
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)