Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

BACKGROUND: Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. METHODS/DESIGN: The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. DISCUSSION: This study evaluates the effectiveness of a comprehensive self-management educational program by a cluster randomized trial within inpatient cardiac rehabilitation in Germany. Furthermore, subgroup-related treatment effects will be explored. Study results will contribute to a better understanding of both the effectiveness and mechanisms of a self-management group program as part of cardiac rehabilitation. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00004841; WHO International Clinical Trials: = DRKS00004841.

Type D personality and all-cause mortality in cardiac patients--data from a German cohort study.

OBJECTIVE: Type D personality has been established as a predictor of adverse clinical events in patients with cardiovascular diseases. To date, all studies except one have been conducted by a single research group. Thus, the aim of our study was to provide an independent replication of the results regarding the prognostic validity of Type D personality in a German sample of cardiac patients. METHODS: Cardiac patients (n = 1040) were recruited from cardiac rehabilitation centers (n = 484), an outpatient clinic (n = 249), and a university hospital (n = 307). Main analyses were based on the combined data from these three subsamples. Cardiac health status, medical risk factors, sociodemographic characteristics, psychological symptoms, and Type D personality were assessed at baseline. The primary end point was all-cause mortality. The Cox proportional hazards regression model was used to estimate the relative risk of death. RESULTS: Vital status was known for 977 patients (22.5% women; mean [standard deviation] = 63.3 [10.7] years). Within the follow-up time (mean [standard deviation] = 71.5 [3.6] months), 172 patients died. Type D personality was found in 25.2% of survivors and in 22.2% of nonsurvivors (χ²= 0.78, p = .38). Depressive symptoms (p = .13) and anxiety (p = .27) were also not predictive of mortality. In the multivariate analyses, neither Type D (p = .95) nor negative affectivity (p = .71) and social inhibition (p = .59), as well as their interaction (p = .88), were associated with all-cause mortality. CONCLUSIONS: In the present study, Type D personality and its constituents are not associated with increased mortality in patients with heart disease. The discrepancies with previous results deserve further investigation.

The impact of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation.

OBJECTIVE: To evaluate a patient-centred self-management educational group program for patients with chronic systolic heart failure as compared to usual care education during inpatient cardiac rehabilitation. METHODS: A multicentre cluster randomized controlled trial of 475 patients was conducted. In the intervention condition, patients received the new self-management educational group program whereas in the control condition, patients received a short lecture-based educational program (usual care). The primary outcome was patients' self-reported self-management competence. Secondary outcomes included self-management health behaviour, health-related quality of life, and treatment satisfaction. Patients completed self-reported outcome measures at admission, discharge, and after 6 and 12 months. RESULTS: There was a significant small between-group intervention effect on certain dimension of patients' self-management competence (self-monitoring and insight) in short term (p<0.05). Furthermore, significant small effects were observed for treatment satisfaction at discharge as well as symptom monitoring after 6 months (p<0.05) and by trend on symptom monitoring and physical activity after 12 months. CONCLUSIONS: The patient-centred self-management program might be more effective in certain self-management outcomes than a usual care education in both short-term and long-term periods. PRACTICE IMPLICATIONS: Therefore, such programs may be considered for dissemination within cardiac rehabilitation.

[Health promotion and inpatient rehabilitation. Long-term effects of education in patients with coronary heart disease]. / Gesundheitsförderung durch eine stationäre Rehabilitation. Langzeiteffekte von Schulungsmassnahmen bei Patienten mit koronarer Herzkrankheit.

BACKGROUND AND PURPOSE: The most important goals in the rehabilitation of patients with a coronary heart disease (CHD) include the diagnosis and treatment of risk factors, health promotion, and education. The knowledge on and awareness of cardiovascular risk factors is an important precondition for a high patient compliance. Former studies on patients in cardiologic departments of hospitals showed no effect of health promotion and education on patients' knowledge on risk factors, presumably because of the setting in acute therapy. Therefore, the possible effects of health promotion and education on the knowledge of patients were studied in the setting of an inpatient rehabilitation. METHODS: Over 1 year, 426 patients, admitted to an inhospital rehabilitation, were questioned on the first and last day of their stay using a validated instrument ("Bochumer Bewertungsbogen-Kardiovaskuläre Risikofaktoren" [BBKR], Table 1). 1 year after discharge, the same questionnaire was sent to the surviving 423 patients. Of these, 267 patients (63.1%) answered. The average age was 64.3 years (standard deviation [SD] 11.3). Demographic data and clinical history are summarized in Table 2. RESULTS: For most of the known risk factors of CHD, the number of patients mentioning them significantly increased during the observation period. On the day of admittance, only 59.2% mentioned diabetes mellitus as a risk factor compared to 74.6% 1 year after discharge. Especially patients with a CHD improved their knowledge on their disease (Figure 1). Education and number of rehabilitations in the past had an influence on the knowledge of interviewed patients on the day of admittance. Especially elderly patients had an increase in knowledge, indicated by a higher score in the questionnaire (Table 3). Participation in patients' self-help meetings within the observation time had no influence on the knowledge. Patients with known hypertension or hyperlipoproteinemia and overweight patients could increase knowledge on the cardiovascular risk of their disease (Figure 2). CONCLUSION: The results of this query document the lack of knowledge on cardiovascular risk factors of patients before rehabilitation. Especially the results of patients with a diagnosed (and treated) CHD after an inpatient stay in an acute hospital in the past were surprising. The stationary rehabilitation is an appropriate measure to improve this knowledge. It can be used for secondary prevention. The raise in knowledge was evident 1 year after discharge; a long-term effect of health education during stationary rehabilitation is likely.

[Evaluation of the German Type D Scale (DS14) and prevalence of the Type D personality pattern in cardiological and psychosomatic patients and healthy subjects]. / Evaluation der deutschen Typ-D-Skala (DS14) und Prävalenz der Typ-D-Persönlichkeit bei kardiologischen und psychosomatischen Patienten sowie Gesunden.

The Type D personality pattern, consisting of negative affectivity and social inhibition, has been shown by Denollet et al. to predict adverse prognosis in patients with coronary heart disease. For measuring the Type D characteristics, Denollet has devised the 14 item Type D scale (DS14). In the present study, this instrument was translated into German. The validity, reliability and adequacy of the German DS14 were then tested in 2421 persons, including cardiological and psychosomatic patients as well as healthy factory workers. The results document sound psychometric properties of the scale. Cronbach's alpha was 0.87 for the negative affectivity subscale and 0.86 for social inhibition. The two-factor structure of the original instrument could be clearly replicated. The prevalence rates of the Type D pattern were lowest in cardiological patients (25 %) and highest in psychosomatic patients (62 %). The prevalence in this German sample of cardiology patients was also lower than the one observed in healthy factory workers (32.5 %) and in CHD samples reported in the literature. These group differences could not be accounted for by differences in age and sex distribution. In conclusion, the DS14 is a valid and reliable instrument that can be used for an economic evaluation of the Type D characteristics in patients and healthy persons. The possible meaningfulness of the low Type D prevalence in cardiac patients and the prognostic relevance of this pattern require further study.