Plain English Summary
Background and study aims
According to the World Health Organization (WHO), around 35% of women and 29% of men have a chronic disease and socio-economic factors, such as poverty and loneliness, have a big influence on how many people have chronic diseases. The cost of chronic conditions is up to 6.8% of the Gross Domestic Product in some European countries. In this study (EFFICHRONIC), the intervention is the Chronic Disease Self-Management Programme (CDSMP). This is a learning program for adults with a chronic condition and caregivers to encourage them to better manage and preserve their health. It was developed at Stanford University and has been positively tested for over 20 years already. The CDSMP intervention is expected to achieve greater advantages in people with a low socioeconomic position (SEP) or those who are isolated, because their disease progression is worse and they tend to adopt less healthy habits compared to citizens with a higher SEP. In the EFFICHRONIC project, pilot sites in five European countries (France, Italy, the Netherlands, Spain, and United Kingdom) apply the CDSMP intervention specifically in citizens with a low SEP and caregivers who live isolated lives.
The aim of EFFICHRONIC is to evaluate the benefits of the CDSMP intervention in vulnerable populations. The following questions will be answered:
1. What are the benefits of the CDSMP intervention on better managing one’s life with regard to healthy lifestyle, handling emotions, correct medication intake, and quality of life?
2. What are the effects of the CDSMP intervention on the frequency of medical errors, the way people communicate with health professionals and the way they find and handle information on health?
3. What are the savings for society of the CDSMP intervention in terms of lowering healthcare use and improving work rate of the participants?
4. What is the grade of satisfaction with the CDSMP intervention of the participants?
Who can participate?
Adults with a chronic condition or caregivers with a low socio-economic level or who don’t have a wide social network
What does the study involve?
The intervention consists of a series of 6 workshops, 2.5 hours each, which are held once a week for 6 weeks. The number of participants per workshop will be between 12 and 20. The participants will be evaluated by means of a self-administered questionnaire before the intervention and 6 months later. An important element of the intervention is education between equals. The workshops are conducted by 2 people, preferably one health professional and one person with a chronic condition. They are previously trained according to the CDSMP principles.
What are the possible benefits and risks of participating?
Participation in the study does not involve any risks or specific benefits, apart from the benefits of the CDSMP intervention itself. Data processing, communication and transfer will be done in accordance with the national regulation and, as of May 25, 2018, in accordance with the General Data Protection Regulation, the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data. Only the research team and the health authorities, who have the duty to maintain confidentiality, will have access to all collected study data. Only information that cannot be identified may be transmitted to third parties. In the event of information transmission to other countries, it will be carried out anonymously with a data protection level according to the Regulation (EU) 2016/679.
Where is the study run from?
The study is coordinated from FICYT and CSPA in Asturias, Spain. The study will be conducted at the following European sites:
1. Centre Hospitalier Universitaire Montpellier (CHUM) in France
2. Ente Ospedaliero Ospedali Galliera in Genoa, Italy
3. Erasmus Universitair Medisch Centrum (EMC) in Rotterdam, the Netherlands
4. Foundation for the Promotion in Asturias of Applied Scientific Research and Technology (FICYT), Regional government of Health in Asturias (CSPA) and Asturias Public Health Service (SESPA) in Spain
5. QISMET, Portsmouth, United Kingdom
When is the study starting and how long is it expected to run for?
June 2017 to July 2020
Who is funding the study?
European Union Health Programme (2014-2020)
Who is the main contact?
Marta Pisano González
martam.pisanogonzalez@asturias.org
Trial website
Contact information
Type
Scientific
Primary contact
Dr Marta Pisano González
ORCID ID
http://orcid.org/0000-0002-6485-9370
Contact details
Ed Buenavista
Ala Oeste 2ª planta
sect izdo
C/ Ciriaco Miguel Vigil
9
Oviedo - Asturias
33006
Spain
+34 985 66 81 53
MartaM.PisanoGonzalez@asturias.org
Type
Scientific
Additional contact
Mrs An LD Boone
ORCID ID
http://orcid.org/0000-0001-5198-8889
Contact details
Ed Buenavista
Ala Oeste 2ª planta
sect izdo
C/ Ciriaco Miguel Vigil
9
Oviedo - Asturias
33006
Spain
+34 985 66 81 53
anboone@ficyt.es
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
738127 / EFFICHRONIC
Study information
Scientific title
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
Acronym
EFFICHRONIC
Study hypothesis
Intervention programs in chronic disease patients within vulnerable populations, based on empowerment and self-care, selected taking into account the social determinants of health, are efficient and improve the sustainability of health services.
Ethics approval
1. In the UK, the study did not need approval from an ethics committee as it was considered to be measuring evaluation and not being investigational, as the effectiveness of the Chronic Disease Self-Management Programme has already been proven in previous studies.
2. Medical Ethics Committee Erasmus MC, 23/11/2017, MEC-2017-1116
3. Research Ethics Committee of the Principality of Asturias (Comité de Ética de la Investigación del Principado de Asturias), 31/01/2017, 20/17
4. Regional Ethics Committee of Liguria (Il Comitato Etico della Regione Liguria), 27/03/2018, 152-2018
5. In France, the Ethics Committee of the South-west and Overseas I (Comité de Protection des Personnes Sud-Ouest et Outre-Mer I) approved of the protocol (study number 9788) on November 5th 2018
Study design
Quasi-experimental prospective multi-centre open-label before-after study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Quality of life
Patient information sheet
Available upon request
Condition
Caregivers and people with chronic conditions in a vulnerable situation considering socio-economic and educational factors
Intervention
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 health, salutogenesis (factors that support human health and well-being), community participation and risk stratification. The primary aim of the intervention is to achieve greater self-management of the chronic condition by changing the role of the passive citizen to empowerment in self-confidence and self-reliance. The intervention consists of a series of 6 workshops, 2.5 hours each, which are held once a week for 6 weeks. The number of participants per workshop is between 12 and 15. Generally, each workshop has between 7 and 8 activities with specific objectives, integrating different techniques (individual work, small and large groups, brainstorming), has an agenda and defined time for each activity, includes a break as a space where participants can start networking. Citizens with a chronic condition are encouraged to self-management by professionals as well as peers (other citizens with a chronic condition). One professional and one peer will volunteer to together lead a series of workshops. The leaders will be recruited and trained in the CDSMP principles. Participants will fill in a questionnaire before the intervention and 6 months later to evaluate the outcomes of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
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 outcome measures
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-familial assessment assessed using change in score between Day 0 and 6 months in the Gijón scale
11. Stratification of the participants by mortality risk using the self-administrated multidimensional prognostic indices (MPI-Chronic) at Day 0 and 6 months
Overall trial start date
01/06/2017
Overall trial end date
31/07/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
2000
Participant 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
Recruitment start date
01/08/2018
Recruitment end date
01/04/2020
Locations
Countries of recruitment
France, Italy, Netherlands, Spain, United Kingdom
Trial participating centre
Foundation For The Promotion In Asturias Of Applied Scientific Research And Technology – (FICYT)
Oviedo
33007
Spain
Trial participating centre
Centre Hospitalier Universitaire Montpellier (CHUM)
34295
France
Trial participating centre
Quality Institute For Self-Management Education And Training (QISMET)
PO6 4ST
United Kingdom
Trial participating centre
Regional Government of Health in Asturias (CSPA)
Oviedo
33006
Spain
Trial participating centre
Asturian Public Health Service (SESPA)
33006
Spain
Trial participating centre
Erasmus University Medical Centre (EMC)
Rotterdam
3015 GD
Netherlands
Trial participating centre
Ente Galliera Hospital (EOG)
Genoa
16128
Italy
Sponsor information
Organisation
Consejería de Sanidad del Principado de Asturias (CSPA)
Sponsor details
Ciriaco Miguel Vigil
9
Oviedo
33005
Spain
Sponsor type
Government
Website
Funders
Funder type
Not defined
Funder name
European Commission - European Union’s Health Programme
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Consejería de Sanidad del Principado de Asturias (CSPA) - Regional Ministry of Health of the Principality of Asturias.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Servicio de Salud del Principado de Asturias (SESPA) - Public Health System of Asturias.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Current publication and dissemination plan as of 01/10/2019:
- Planned publication in minimum 5 high-impact peer-reviewed journals.
- Two Open Access articles related to the project have been published:
1. Pilotto A, Veronese N, Quispe K, et al. Development and validation of a self-administered Multidimensional Prognostic Index (SELFY-MPI) to predict negative health outcomes in community-dwelling persons. Rejuvenation research 2019; 22(4): 299-305.
doi: 10.1089/rej.2018.2103.
2. Tan SS, Pisano MM; Boone AL et al., Evaluation Design of EFFICHRONIC: The Chronic Disease Self-Management Programme (CDSMP) Intervention for Citizens with a Low Socioeconomic Position. Int. J. Environ. Res. Public Health 2019, Volume 16, Issue 11, 1883. doi:10.3390/ijerph16111883.
3. Furthermore, we are planning to publish also the study protocol (which is under revision at this time) and at least three articles: on the recruitment strategies, the implementation of the selfy-MPI and the results of the project evaluation.
Added 10/06/2020: 3. Boone ALD, Pisano-Gonzalez MM, Valsecchi V, et al. EFFICHRONIC study protocol: a non-controlled, multicentre European prospective study to measure the efficiency of a chronic disease self-management programme in socioeconomically vulnerable populations. BMJ Open.
2019;9(12):e032073. Published 2019 Dec 18. doi:10.1136/bmjopen-2019-032073
Previous publication and dissemination plan:
- Planned publication in minimum 5 high-impact peer-reviewed journals.
- One article related to the project was published:
Pilotto et al. “Development and validation of a self-administered Multidimensional Prognostic Index (SELFY-MPI) to predict negative health outcomes in community-dwelling persons”.
DOI: 10.1089/rej.2018.2103. Available online. Rejuvenation Research, 2018. Published in Open Access.
- One article was submitted to BMC Public Health on November 24th 2018: Tan et al. “Evaluation design of EFFICHRONIC: Enhancing health systems sustainability by providing (cost-) effectiveness data of an evidence-based intervention for chronic management in citizens with a low socioeconomic status”. It is currently under editorial review.
- Furthermore, we are planning to publish at least the protocol, an article on recruitment strategies and the results of the project evaluation. We will provide you with more details once the publication process started.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date. All data shared during or after the project execution will be anonymized.
Intention to publish date
30/09/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2019 pilot study in https://www.ncbi.nlm.nih.gov/pubmed/30382001 (added 01/10/2019)
2019 design evaluation in https://www.ncbi.nlm.nih.gov/pubmed/31142017 (added 01/10/2019)
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31857305/ (added 10/06/2020)