M15 M16 M17
Conditions
Interventions
Group 1: Intervention group: Implementation of the SmArt-E program
Patients undergo a digitally guided training and education program. The intervention period is twelve months and consists of the foll
Sponsors
Deutsches Zentrum für Luft- und Raumfahrt e. V. (DLR)
Eligibility
Sex/Gender
All
Age
38 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion: Medically/physician-diagnosed osteoarthritis (ICD-10-GM: M.15 polyarthrosis, M16.- coxarthrosis, and M17. gonarthrosis) and fulfillment of the American College of Rheumatology criteria for knee/hip osteoarthritis. Age >50 and >38 years for hip and knee osteoarthritis, respectively.
Exclusion criteria
Exclusion criteria: Exclusion of participants who have already had joint replacement of the affected index joint (total joint arthroplasty).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| #1a: Hip Disability and Osteoarthritis Outcome Score (HOOS) OR #1b: Knee Injury Osteoarthritis Outcome Score (KOOS) AND #2: Numeric Rating Scale (NRS) to assess pain severity AFTER completion of the entire intervention (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| Three assessments are scheduled: 1. T0 assessment = following enrolment and before randomization/ start of the intervention; 2. T1 assessment = 3 months after the start of the intervention/ after completion of the face-to-face intervention; 3. T2 = after completion of the 12-months study period. 1. HOOS or KOOS and NRS after 3 months 2. Physical performance tests (modified Y-Balance Test; 30-second Sit-to-Stand Test) after 3 and 12 months 3. Daily physical activities (assessment is device-based and questionnaire-based) after 3 and 12 months Questionnaire surveys: 4. Action and coping planning (Action Planning & Coping Planning) at 3 and 12 months. 5. Quality of life/ health status (European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-3L), Patient Global Assessment (PGA) and self-rated change in health status after 3 and 12 months 6. Assessment of coping strategies for pain and its evaluation (Pain Catastrophizing Scale, PCS) after 3 and 12 months 7. Self-report behavioral automaticity index (SRBAI) after 3 and 12 months 8. Assessment of the general improvement of the disease (Patient Acceptable Symptom Scale, PASS) after 3 and 12 months 9. Self-efficacy/ empowerment (Arthritis Self-Efficacy Scale, ASES) after 3 and 12 months 10. Patient satisfaction (ZUF-8) and an additional item assessing the patient's perspective on the satisfaction with the results of the treatment after 3 and 12 months 11. Physical activity health competence (short form) after 12 months 12. Usability: System Usability Scale (SUS) after 3 months and mHealth App Usability Questionnaire (MAUQ) after 12 months 13. Questions on health care expenditures (financial expenditures due to osteoarthritis-related knee/hip problems for utilization of health care providers, therapeutic treatments, aids, etc.) for the period 12 months before study inclusion and during the 12-months intervention period | — |
Countries
Germany
Contacts
Public ContactSara Neumann
Hochschule für Gesundheit Bochum, Department für Angewandte Gesundheitswissenschaften
Outcome results
None listed