Effectiveness of a self-management patient education program "Curriculum Heart Failure" for inpatient cardiac rehabilitation.

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00004841
• Date of registration: 05/04/2013
• Prospective Registration: No
• Primary sponsor: Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften
• Public title: Effectiveness of a self-management patient education program "Curriculum Heart Failure" for inpatient cardiac rehabilitation.
• Scientific title: Effectiveness of a self-management patient education program "Curriculum Heart Failure" for inpatient cardiac rehabilitation.
• Date of first enrolment: 02/01/2012
• Target sample size: 540
• Recruitment status: Complete
• URL: http://drks.de/search/en/trial/DRKS00004841
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: other; Study design purpose: treatment
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Karin Meng
• Affiliation: Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften

• Name: Karin Meng
• Affiliation: Universität Würzburg, Abteilung für Medizinische Psychologie und Psychotherapie, Medizinische Soziologie und Rehabilitationswissenschaften

Key inclusion & exclusion criteria

Inclusion criteria: Chronic systolic heart failure HF (ICD-10: I50), left ventricular ejection fraction LVEF of 40 or less, and New York Heart Association NYHA functional classification of class II or III.
Exclusion criteria: Acute events of decompensation, cognitive impairment, inadequate German language ability, and severe visual or hearing impairment.

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

Heart failure

I50

Intervention(s)

Group 1: Intervention condition is a new self-management educational program “Curriculum Heart Failure” that consists of 5 patient-oriented, interactive sessions of 60 or 75 minutes each, which are held in small groups of a closed format (15 participants or less). The program is manual-based and interdisciplinary with sessions led by a physician, a nurse, a psychologist and a physiotherapist, respectively. In each session, patients are actively involved in the educational process using a combination of didactic methods (short lectures, group discussion, practice, partner and individual work). Didactic materials included presentations, flipcharts, and two patient booklets (educational booklet with HF information and worksheets, symptom-monitoring diary for six months). Contents of the lessons include HF illness and treatment knowledge (e.g. aetiology, symptoms and signs, diagnostic, medical treatment options, medication) with regard to individual needs of the participants. Furthermore, there is a focus on self-management behaviors (e.g. dietary restrictions, attention to deterioration signs/symptoms, and daily weight and blood pressure monitoring) and medication adherence. To promote physical activity theory-based intervention techniques are applied (e.g. action and coping planning, self-monitoring). Additionally, signs of emotional distress according to HF and coping strategies are discussed.
Group 2: Control condition is treatment as usual. One lecture of basic medical education by a physician with duration of about 60 minutes. Information is mostly presented in a vertical manner. Contents included basic heart failure illness information on aetiology, symptoms and signs, pharmacological treatment, surgery, and self-management recommendations (e.g. symptom monitoring

Primary Outcome(s)

1) Self-management competence; Health Education Impact Questionnaire HeiQ - Scales Self-monitoring and insight, Skill and technique acquisition (german version; Schuler et al., 2012); time frame: admission, discharge, after 6 months, after 12 months.
2) Self-efficacy; Kansas City Cardiomyopathy Questionnaire KCCQ (german version; Faller et al., 2005); time frame: admission, discharge, after 6 months, after 12 months.

Secondary Outcome(s)

1) Behavioral determinants: 1.1) Symptom control; adapted questionnaire for habit strength (Fleig et al., 2011); time frame: after 6 months, after 12 months. 1.2) Physical activity; HAPA-scales (Schwarzer et al., 2007; Sniehotta et al., 2005), modifiend version of Self-Report Habit Index SRHI (Fleig et al., 2011); time frame: admission, discharge, after 6 months, after 12 months. 1.3) Medication beliefs. Beliefs about Medicine Questionnaire BMQ-D (Horne & Weinman, 1999; german version, Opitz et al., 2008); time frame: admission, discharge, after 6 months, after 12 months.
2) Self-management behavior: 2.1) Symptom control; short questionnaire developed by our research group; time frame: admission, after 6 months, after 12 months. 2.2) Physical activity; Godin Leisure-Time Exercise Questionnaire, modified version (Godin et al., 1985); time frame: admission, after 6 months, after 12 months. 2.3) Medication adherence; Medication Adherence Report Scale MARS-D (german version; Mahler et al., 2010); time frame: admission, after 6 months, after 12 months. 2.4) Smoking; single items (www.gbe-bund.de); time frame: admission, discharge, after 6 months, after 12 months. 3) Health-related quality of life; Kansas City Cardiomyopathy Questionnaire KCCQ (german version; Faller et al., 2005); time frame: admission, discharge, after 6 months, after 12 months. 4) cardiac events; time frame: after 6 months, after 12 months. 5) treatment satisfaction; short questionnaire developed by our research group (Meng et al., 2009); time frame: discharge.

Source(s) of Monetary Support

Deutsche Rentenversicherung Bund

Ethics review

Status: Approved
Approval date: 19/04/2011
Contact:

[e-mail]

Ethik-Kommission der Universität Würzburg, Institut für Pharmakologie und Toxikologie

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 24/01/2023
• Date Completed: 31/12/2014
• URL: http://drks.de/search/en/trial/DRKS00004841#studyResults