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Effectiveness and cost-effectiveness of a health coaching intervention to improve the lifestyle of patients with knee osteoarthritis

Effectiveness and cost-effectiveness of a health Coaching intervention to improve the lifestyle of Patients with Knee OsteoArthritis: a cluster randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57405925
Enrollment
360
Registered
2013-12-20
Start date
2014-02-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Knee osteoarthritis Musculoskeletal Diseases Gonarthrosis [arthrosis of knee]

Interventions

Randomization: To avoid contamination between study groups, the PHCC will be the randomization unit. The PHCCs that agree to participate will be allocated either to the intervention or the control gro

Sponsors

IDIAP Jordi Gol (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Phase 1. The four discussion groups will include 8-12 primary care professionals working with patients with osteoarthritis Phase 2. 1. Level 1 - Inclusion criteria to be determined by the physician: 1.1. Primary care patients with clinical and radiological diagnosis of knee osteoarthritis in the Kellgren-Lawrence stages 1-3 1.2. To be able to read and write 1.3. To have a mobile phone 1.4. To be able to go to the primary health care centres (PHCC) 1.5. To agree to participate 2. Level 2 - Inclusion criteria to be determined by the psychologist: 2.1. Patients that deliver the 'commitment folder' within the period agreed Phase 3. The four discussion groups will include 8-12 primary care professionals working with patients with osteoarthritis

Exclusion criteria

Exclusion criteria: Phase 2. Exclusion criteria: 1. Patients with knee osteoarthritis in the Kellgren-Lawrence stages 0 and 4 2. Patients with rheumatoid arthritis, fibromyalgia and other systemic rheumatological conditions 3. Patients on a waiting list for orthoses 4. Patients admitted during the past three months for cardiovascular diseases 5. Patients suffering from Parkinson disease, Paget?s disease, cognitive deterioration, metastatic cancer, severe mental diseases and personality disorders 6. Women who are pregnant or planning a pregnancy

Design outcomes

Primary

MeasureTime frame
1. Quality of life as measured by the WOMAC index (Batlle, 2009). The results will be measured in both groups three weeks before the intervention, immediately after the Intensive Phase and after 3, 6 and 12 months of recruitment. 2. Weight in kilograms and physical activity will be registered monthly. The weight will always be obtained using the same scale of the PHCC. 3. During the first interview we will obtain the height (in meters).

Secondary

MeasureTime frame
Clinical dependent variables: 1. Pain (ICOAP, Maillafet, 2009) 2. Weight (in kg. Scale at PCC) 3. Physical Activity (IPAQ- Puig, 2012, Pedometer) 4. Nutrition (PREDIMED) Clinical variables: Drug prescription, diagnostic tests, waist circumference, height, co-morbidities, duration of disease in years, duration of knee osteoarthritis in years (all with ad-hoc questionnaire). Cost-related variables: 1. Direct medical costs: 1.1. Cost of coaching in osteoarthritis intervention 1.2. Cost of visits to the GP 1.3. Cost of visits to the nurse 1.4. Cost of visits to the physiotherapist 1.5. Cost of visits to specialist MD 1.6. Cost of medical tests 1.7. Cost of pharmacological treatment 1.8. Operating costs of the PCC 1.9. Cost of disposable medical equipment 1.10. Cost of transport (ambulance) 1.11. Cost of home assistance 2. Indirect medical costs: costs due to loss of productivity (days of sick leave)

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026