Feed-bApp – Feedback Features of Varying (Cost-)Intensity in a Paediatric Pain App and Their Influence on Quality of Care

Feed-bApp – Feedback Features of Varying (Cost-)Intensity in a Paediatric Pain App and Their Influence on Quality of Care - Feed-bApp

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00030665

Enrollment

416

Registered

2022-11-02

Start date

2022-12-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F45.40 F45.41

Interventions

Group 1: Access to app after baseline survey (T1), activation of feedback level 1 after discharge (T2)

access to app for 6 months Group 2: Access to app after baseline survey (T1), activation of feedback levels 1+2 after discharge (T2)

access to app for 6 months Group 3: Access to app after baseline survey (T1), activation of feedback levels 1+2+3 after discharge (T2)

access to app for 6 months Group 4: Access to app after baseline survey (T1), activation of feedback levels 1+2+3+4 after discharge (T2)

access to app for 6 months

Eligibility

Sex/Gender

All

Age

8 Years to 17 Years

Inclusion criteria

Inclusion criteria: chronic pain (ICD-10: F45.40 or F45.41), Inpatient pain therapy at one of the four participating pain centers (Augsburg, Datteln, Garmisch-Partenkirchen, Stuttgart), i.e. stay of at least 7 days and participation in at least one family session, Access to a smartphone, tablet or PC and internet in the home environment for patient and parents, Informed consent to study participation

Exclusion criteria

Exclusion criteria: Withdrawal of consent to study participation

Design outcomes

Primary

Measure	Time frame
Quality of care assessed by: Patients’ and parents’ satisfaction with the app (T2-T5) and feedback (T3-T5) based on a validated global measure of treatment satisfaction (Stahlschmidt et al., 2018), Patient-reported functional disability in everyday life assessed with validated German version of the FDI (T1-T5). T5 (9 months after discharge and thus 3 months after deactivation of the app) is set as the primary endpoint.	—

Measure

Time frame

Quality of care assessed by: Patients’ and parents’ satisfaction with the app (T2-T5) and feedback (T3-T5) based on a validated global measure of treatment satisfaction (Stahlschmidt et al., 2018), Patient-reported functional disability in everyday life assessed with validated German version of the FDI (T1-T5). T5 (9 months after discharge and thus 3 months after deactivation of the app) is set as the primary endpoint.

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Secondary

Measure	Time frame
Patients: Pain characteristics and school absence due to pain (DSF-KJ), Maximum and average pain intensity (NRS 0-10) (T1-T5), Anxiety and Depression (validated German version of the RCADS) (T1-T5), Self-efficacy (Scale for Pain Self-Efficacy, S³) (T1-T5), Treatment adherence (based on app usage data and application of pain management strategies collected by the app, and self-report in electronic data collection) (T2-T5), Patient-HCP-relationship and overall treatment satisfaction (version of HAQ adapted for patients) (T2-T5). Parents: Treatment adherence (based on app usage data and self-report in electronic data collection) (T2-T5), Parental responses to child pain (ISEV-E) (T1-T5), Confidence in handling the child’s pain (global judgement; NRS 0-10), Parent-HCP-relationship and overall treatment satisfaction (version of HAQ adapted for parents) (T2-T5), Parental pain (adapted from DSF-KJ), Resource use and productivity loss (health economic analysis; adapted and translated version of the TiC-P) (T1, T3-T5).	—

Measure

Time frame

Patients: Pain characteristics and school absence due to pain (DSF-KJ), Maximum and average pain intensity (NRS 0-10) (T1-T5), Anxiety and Depression (validated German version of the RCADS) (T1-T5), Self-efficacy (Scale for Pain Self-Efficacy, S³) (T1-T5), Treatment adherence (based on app usage data and application of pain management strategies collected by the app, and self-report in electronic data collection) (T2-T5), Patient-HCP-relationship and overall treatment satisfaction (version of HAQ adapted for patients) (T2-T5). Parents: Treatment adherence (based on app usage data and self-report in electronic data collection) (T2-T5), Parental responses to child pain (ISEV-E) (T1-T5), Confidence in handling the child’s pain (global judgement; NRS 0-10), Parent-HCP-relationship and overall treatment satisfaction (version of HAQ adapted for parents) (T2-T5), Parental pain (adapted from DSF-KJ), Resource use and productivity loss (health economic analysis; adapted and translated version of the TiC-P) (T1, T3-T5).

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Countries

Germany

Contacts

Public ContactAmelie Schmidt

PedScience Vestische Forschungs-gGmbH

a.schmidt@pedscience.de02363-975-2013

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026