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EFFICHRONIC: Efficiency analysis of a self-management programme in 5 European countries, in vulnerable people with chronic diseases and/or their caregivers

Enhancing health systems sustainability by providing cost-EFFIciency data of evidenced based interventions for CHRONIC management in stratified population based on clinical and socio-economic determinants of health

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN70517103
Enrollment
2000
Registered
2018-06-20
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Caregivers and people with chronic conditions in a vulnerable situation considering socio-economic and educational factors Other Chronic disease

Interventions

The underlying conceptual elements of the Chronic Disease Self-Management Programme (CDSMP) programme are self-efficacy, empowerment, peer-to-peer education, recognition of the social determinants of

Sponsors

Consejería de Sanidad del Principado de Asturias (CSPA)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Isolated caregivers: 1. Takes care of someone with an illness 2. Vulnerability condition of isolation, such as (but not only): 2.1. Without means of transport or limited access to it 2.2. No Internet access 2.3. No or limited social support Vulnerable people with a chronic disease: 3. Has a chronic disease (self-reported or clinically evaluated by medical staff) according to the International Classification of Primary Care (ICPC-2), i.e. a chronic pathology with code between 70 and 99 registered in one of the 17 chapters and more than 6 months of evolution 4. Has a vulnerability condition, such as (but not only): 4.1. Elderly (aged >65 years) living alone or in a nursing home 4.2. Prisoners 4.3. Ethnic minorities on a low income, i.e. finds it difficult to make ends meet 4.4. Legal immigrants on a low income, i.e. finds it difficult to make ends meet 4.5. Other vulnerable persons on a low income even if not included in the previous target groups

Exclusion criteria

Exclusion criteria: 1. Aged <18 years 2. Experiencing a period of crisis (domestic violence, refugees without a stable environment, eviction, etc) 3. Basic housing needs not met (homeless or roofless) 4. Diagnosed with severe mental health problems (according to DSM V, e.g. psychosis) with distorted perception of reality and/or inability to function in a group 5. Cognitive decline (e.g. Alzheimer's disease), identified as a score from 43 to 50 on the “Test Your Memory” test 6. Active addictive disorders (drugs, alcohol) 7. Inadequate knowledge of the language of the country of residence

Design outcomes

Primary

MeasureTime frame
Change in quality of life as measured by the Physical and Mental Component Summary Scale scores of the 12-Item Short Form Health Survey (SF-12) between Day 0 and 6 months

Secondary

MeasureTime frame
1. Health status and wellbeing assessed using change in score for the following questionnaires between Day 0 and 6 months: 1.1. Health status: change in score between Day 0 and 6 months in the EQ-5D-5L 1.2. Sleep and fatigue were measured separately with a visual numeric scale 1.3. Depression: Personal Health Questionnaire Depression Scale (PHQ) 2. Healthy behaviour assessed using change in score for the following questionnaires between Day 0 and 6 months: 2.1. Physical exercise: Exercise Behaviours questions (EB) and the International Physical Activity Questionnaires (IPAQ) (question 7) 2.2. Healthy eating measured by asking 3 questions on the usual intake of fruits, vegetables, and breakfast 2.3. Addictions: alcohol (Alcohol use disorders test-AUDIT) and smoking assessed by asking participants if they smoke (yes/no) at the time of the questionnaire 3. Communication: 3.1. Change in score between Day 0 and 6 months in communication with physician questionnaires (CP) 3.2. Percentage of positive answers on interpersonal communication skills at 6 months after the programme only 4. Self-management assessed using change in score between Day 0 and 6 months in the Self-Efficacy for Managing Chronic Disease (CDSE) scale. 5. National Health System confidence using percentage of positive answers on the confidence in the National Health System at 6 months after the programme 6. Health-economic assessment using change in score between Day 0 and 6 months in the SMRC Health Care utilization questionnaire and in the Productivity Cost Questionnaire 7. Treatment Adherence assessed using change in score between Day 0 and 6 months in the Short Medication Adherence Questionnaire (SMAQ) 8. Medical error experience assessed using change in score between Day 0 and 6 months on the question concerning medical error (AARP) 9. Critical thinkin assessed using change in score between Day 0 and 6 months in 2 items of the Consortium for the European Health Literacy Survey (HLS-EU) 10. Socio-f

Countries

England, France, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 20, 2026