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Implementing the concepts of mindfulness and community engagement to self-manage chronic diseases in four European cities

Social engagement framework for addressing the chronic disease challenge (SEFAC)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11248135
Enrollment
360
Registered
2018-08-30
Start date
2018-06-01
Completion date
Unknown
Last updated
2022-11-07

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

Conditions

Citizens at risk of or has coronary heart disease and/or type 2 diabetes mellitus Circulatory System

Interventions

1. The SEFAC model was designed and developed by SEFAC partners and based on the concepts of mindfulness, community engagement as well as ICT support. The model consists of a series of 3-7 workshops f
they will focus on healthy eating, healthy physical activity, healthy relationships and healthy life with chronic conditions. Over these 3-7 workshops, participants learn to recognize the importance o

Sponsors

Erasmus MC university medical center, department of Public Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged =18 years 2. Chronic condition (self-reported or clinically diagnosed by medical staff) defined as: 2.1. A chronic pathology with code between 70 and 99 registered in one of the 17 chapters of the International Classification of Primary Care (ICPC-2) 2.2. More than 6 months of evolution 3. Has caregiver 4. Low perceived self-efficacy (SEP) 5. Expected to be able to participate in the study for at least 6 months

Exclusion criteria

Exclusion criteria: 1. Cannot adequately understand the information provided in the language of the country of residence 2. Experiencing a period of crisis (e.g. domestic violence, impending eviction) 3. Basic housing needs not met (e.g. being homeless) 4. Diagnosed with severe unstable mental health problems (accoring to DSM V; e.g. psychosis) 5. Active addictive disorders (e.g. alcohol addiction) 6. Cognitive decline (e.g. Alzheimer's disease)

Design outcomes

Primary

MeasureTime frame
1. Self-management assessed using the short 6-item version of the Chronic Disease Self-Efficacy instrument (CDSE-6), which measures the confidence in one’s ability to deal with health problems. It covers domains that are common across many chronic conditions, such as symptom control, role function, emotional functioning and communicating with physicians 2. Healthy lifestyle measured with six items on physical exercise (developed for the Stanford CDSMP intervention), three items on healthy eating (intake of fruits, vegetables, and breakfast), one item from the International Physical Activity Questionnaire (IPAQ) on sedentary behavior, one item on smoking and one item from the AUDIT-C on alcohol use 3. Depression measured with the 8-item Patient Health Questionnaire depression scale (PHQ-8) 4. Sleep and fatigue measured by visual analog scales (developed specifically for the Stanford intervention). Participants are asked to indicate how they experience the severity of their sleeping problems and fatigue during the last week on a scale from 0 (no sleeping problem/fatigue) to 10 (severe sleeping problem/fatigue) 5. Adherence to medication is measured with six items from the Short Medication Adherence Questionnaire (SMAQ), a short tool based on questions posed directly to the participant regarding his/her medication-taking habits 6. HR-QoL is measured with the 12-item short-form (SF-12) and the EQ-5D-5L instrument.. The SF-12 is a patient-reported survey which includes both a physical dimension (physical functioning, role-physical, pain and general health) and a mental dimension (vitality, social functioning, role-emotional, and mental health). The EQ-5D-5L is often used in health economics as a variable in the quality-adjusted life year calculation to determine the cost-effectiveness of an intervention. It has five dimensions: mobility, self-care, activity, pain and anxiety. Each dimension h

Secondary

MeasureTime frame
1. Prevalence of medical errors experienced is measured using 3 items from the American Association of Retired Persons (AARP) ‘survey beyond 50.09’ questionnaire 2. Communication with healthcare providers is measured with a scale of 3 items which measures the change in key behaviors concerning communicating with healthcare providers, a scale developed by the Self-Management Resource Center (SMRC) 3. Health literacy is measured with 2 questions from the Health Literacy Questionnaire (HLQ), which was designed using a validity-driven approach and which is used in many countries and in many settings 4. Healthcare utilization is measured with 4 questions from the SMRC Health Care Utilization questionnaire regarding doctor appointments, the use of hospital emergency rooms and hospital admissions 5. Productivity losses are measured with two domains from the Productivity Costs Questionnaire (PCQ): Lost productivity at paid work due to absenteeism (6 items) and lost productivity at unpaid work (3 items) 6. Various socio-demographic characteristics are measured, such as age, gender, country of birth, educational level and employment situation. Any additional remarks can be left in an open box at the end of the questionnaire Data will be collected from participants before the start of the first workshop session (baseline, T0) and 6 months (T1) later. The T0 and T1-questionnaire will be almost identical, with the exception of six additional items which will measure the general satisfaction of the target population with the intervention. In the T1-questionnaire, three items will measure the experienced improvement in specific elements (problem solving, decision making, and confidence building), one additional item relates to the participants’ confidence in their national health system, another refers to improvement of interpersonal communication skills and a sixth supplementary item

Countries

Croatia, England, Italy, Netherlands, United Kingdom

Contacts

Public ContactDemi Cheng
d.cheng.1@erasmusmc.nl-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026