Mindfulness training for patients with structural heart disease.

Randomized controlled trial of mindfulness training as complementary therapy in adults with structural heart disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26153

Enrollment

330

Registered

2012-05-22

Start date

2012-06-04

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

English: Patients with known structural heart disease (congenital heart disease and cardiomyopathy) Dutch: Patienten bekend met een structurele hartaandoening (aangeboren hartafwijking of cardiomyopathie)

Interventions

Intervention: The intervention is a mindfulness training and consists of a structured standardized online program, which has been provided to clients in the general population (http://www.psychologie

Eligibility

Inclusion criteria

Inclusion criteria: Adults 18 to 65 years old known to have structural heart disease, including congenital heart disease and cardiomyopathy.

Exclusion criteria

Exclusion criteria: 1. Planned operation or percutaneous intervention; 2. Inability or unwillingness to give informed consent; 3. Inability to understand Dutch, inability to read or write Dutch; 4. No internet access or no email or no cell phone; 5. Patients who do not fill out their baseline questionnaires or do not show up for the scheduled baseline tests.

Design outcomes

Primary

Measure	Time frame
The 6 minute walk test has been chosen as primary outcome since it is a measure of cardiac and overall physical fitness.	—

Secondary

Measure	Time frame
Key secondary outcome: 1. Quality-of-life (SF36), using the mental- and physical composite outcome scales. Other secondary outcomes: 1. Heart rate, blood pressure, resting respiratory rate (markers of cardiac fitness); 2. NTproBNP (a biomarker for heart failure); 3. Cumulative cortisol in 2 cm of hair taken from the scalp (cumulative measure of stress); 4. Composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac surgery, percutaneous cardiac intervention, electrical cardioversion); 5. Psychological well-being (Hospital Anxiety Depression questionnaire); 6. Preference values (societal EuroQol EQ-5D-5L values, societal SF-6D values obtained from the SF-36, VAS rating scale [Philip Moons version]); 7. Social support (perceived social support scale 12 Blumenthal PSSS12); 8. Medical consumption of health-care use; 9. Health care costs; 10. Related non-health care costs (Tic-P).	—

Measure

Time frame

Key secondary outcome: 1. Quality-of-life (SF36), using the mental- and physical composite outcome scales. Other secondary outcomes: 1. Heart rate, blood pressure, resting respiratory rate (markers of cardiac fitness); 2. NTproBNP (a biomarker for heart failure); 3. Cumulative cortisol in 2 cm of hair taken from the scalp (cumulative measure of stress); 4. Composite endpoint (all-cause mortality, heart failure, arrythmia, cardiac surgery, percutaneous cardiac intervention, electrical cardioversion); 5. Psychological well-being (Hospital Anxiety Depression questionnaire); 6. Preference values (societal EuroQol EQ-5D-5L values, societal SF-6D values obtained from the SF-36, VAS rating scale [Philip Moons version]); 7. Social support (perceived social support scale 12 Blumenthal PSSS12); 8. Medical consumption of health-care use; 9. Health care costs; 10. Related non-health care costs (Tic-P).

—

Contacts

Public ContactJ.O. Younge

Dept. of Cardiology and Dept. of Epidemiology P.O. Box 2040

j.younge@erasmusmc.nl+31 (0)10 7033989

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)