The Efficacy of Goal Setting in Cardiac Rehabilitation
A gender-specific randomized controlled trial
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Background: Patients with coronary heart disease undergo cardiac rehabilitation in order to reduce their cardiovascular risk factors. Often, however, the benefit of rehabilitation is lost over time. It is unclear whether this happens in the same way to men and women. We studied whether the setting of gender-specific behavior goals with an agreement between the doctor and the patient at the end of rehabilitation can prolong its positive effects.
Methods: This study was performed with a mixed-method design. It consisted of qualitative interviews and group discussions with patients, doctors and other treating personnel, and researchers, as well as a quantitative, randomized, controlled intervention trial in which data were acquired at four time points (the beginning and end of rehabilitation and then 6 and 12 months later). 545 patients, 262 of them women (48.1%), were included. The patients were assigned to a goal checking group (n = 132), a goal setting group (n = 143), and a control group (n = 270). The primary endpoints were health-related behavior (exercise, diet, tobacco consumption), subjective state of health, and medication adherence. The secondary endpoints included physiological protection and risk factors such as blood pressure, cholesterol (HDL, LDL, and total), blood sugar, HbA1c, and body-mass index.
Results: The intervention had no demonstrable effect on the primary or secondary endpoints. The percentage of smokers declined to a similar extent in all groups from the beginning of rehabilitation to 12 months after its end (overall figures: 12.4% to 8.6%, p <0.05). The patients’ exercise behavior, diet, and subjective state of health also improved over the entire course of the study. Women had a healthier diet than men. Subgroup analyses indicated a possible effect of the intervention on exercise behavior in women who were employed and in men who were not (p<0.01).
Conclusion: The efficacy of goal setting was not demonstrated. Therefore, no indication for its routine provision can be derived from the study results.
Disorders of the cardiovascular system continue to be the most common cause of death in Germany. Among deaths from all causes, the proportion of cardiovascular disorders was 38.9% in 2014, with coronary heart disease being the most important specific cause of death (1).
Measures taken in secondary prevention that aim to prevent a further coronary event after successful therapy are of fundamental importance, among others. It is well known that cardiovascular risk factors decrease in the context of subsequent curative treatment (phase II) (2, 3). However, these positive effects often disappear in phase III of rehabilitation, which comprises lifelong follow-up care delivered in patients’ places of residence. In order to ensure the sustained effectiveness of cardiac rehabilitation measures, long-term aftercare programs are suitable, which in recent years have been undertaken on the basis of various different concepts. These programs primarily aim to stabilize physical performance and reduce behavior-related risk factors (such as smoking) (4–13).
Setting goals may be a useful tool for stabilizing health-promoting behaviors; this has not become established to a satisfactory degree in routine rehabilitation practice, and little is known about its effectiveness. Furthermore, a substantial need exists for studies investigating which gender-specific elements may have a secondary preventive benefit for patients undergoing rehabilitation (14).
We aimed to develop, implement, and evaluate an intervention in which the patient undergoing rehabilitation and their doctor agree on goals in terms of behavioral (physical activity, diet, tobacco consumption) and physiological (hyperlipidemia, hypertension, diabetes, body weight) risk factors and protection factors at the end of the rehabilitation measure and follow this up three months later. The primary endpoints were behaviors related to physical activity and diet/nutrition, tobacco consumption, subjective state of health, and medication adherence. As our secondary result parameters, we collected data on physiological protection factors and risk factors (systolic and diastolic blood pressure; total cholesterol, HDL cholesterol, and LDL cholesterol concentrations; blood glucose levels; HbA1c; and body mass index). We explored gender-specific ideas of goals and studied the effect of agreed goals on health behaviors and risk profiles.
We used a mixed methods study design (15). In the qualitative study phase, guideline-based interviews and group discussions with patients and medical experts were conducted in order to identify personal goal statements. In order to test the hypothesis of whether goal setting has a positive effect on health behaviors, we subsequently conducted a randomized controlled intervention study with four measurement dates (start [T1] and end [T2], as well as 6 [T3] and 12 [T4] months after the end of the rehabilitation measure). 545 patients were included (of whom 48.1% were female); these were randomly allocated to three study arms: the goal checking group IGa (n = 132), where the investigators conducted a goal setting interview with the patients at the end of the rehabilitation measure and a goal checking interview 3 months after its end; the goal setting group IGb (n = 143), where the goal setting talk took place at the end of the rehabilitation measure; and the control group CG (n = 270), in which patients received routine treatment (Figure 1). The methods are described in detail in the eSupplement.
The study (CARO-PRE II) gained approval from the ethics committee at Charité–Universitätsmedizin Berlin (EA1/056/11) and was registered with the German Clinical Trials Register (DRKS00003568). The study period ran from January 2011 to December 2014.
The primary endpoints were defined as change in physical activity, dietary habits, tobacco consumption, subjective state of health, and medication adherence over time. Physical activity was operationalized by using the data collection instrument by Singer and Wagner (16) and dietary habits by using the food frequency list by Winkler and Döring (17). In order to assess participants’ current subjective state of health, we used the visual analog scale (EQ-VAS), which is a part of the EuroQol questionnaire (18). The Morisky score (19) was used to document medication intake behaviors (medication adherence). In order to capture smoking behaviors, patients’ current status (smoker/non-smoker) was recorded.
We developed an intervention consisting of the following elements:
- Goal setting at the end of the rehabilitation measure: patient and doctor set out and record goals for behavior-related protection factors and risk factors.
- Goal checking three months after the end of the rehabilitation measure: reflecting on goal adherence and offering support if practical implementation caused difficulty.
- Information brochure for patients, which contained disorder-specific information.
- Patient passport to document the measured values for the physiological protection factors and risk factors.
- Instruction manual for doctors on standardized interviewing for goal setting and goal checking.
The three study groups were analyzed by using latent change models with regard to the described endpoints (20). The significance level for the primary endpoints was defined as α = 0.01 after Bonferroni correction for multiple statistical tests.
Qualitative study phase
The evaluation of the interviews conducted with 20 rehabilitation patients showed that men and women were not fundamentally different in the total number of behavioral goals set (with a mean of 7 goals each). However, the substance of the goals they named for the time after the rehabilitation therapy differed.
Male rehabilitation patients set themselves goals mainly in the area of physical activity (56%), followed by goals within their careers (18%) and diet/nutrition (16%). Female patients named only half as many goals in the context of physical activity as male patients. In addition to physical activity (27%), changing their dietary habits was the second most important goal for women (25%), followed by goals relating to their careers (22%). Two months after the end of the rehabilitation measure, women had realized 74% of their goals and men 57% (21). The analysis of the interviews with experts and patients implied a need for support for women with regard to physical activity and for men with regard to a healthier diet/nutrition.
Quantitative study phase
Baseline analyses—545 patients were included in the analysis of the baseline data; 283 (51.9%) of these were men and 262 (48.1%) women. 309 (56.7%) of patients were treated in inpatient rehabilitation centers and 236 (43.3%) in outpatient centers. Table 1 shows relevant sociodemographic, disorder related, and behavior related patient characteristics in the three study groups. No significant differences existed in the groups for all variables under study. The three study arms can therefore be regarded as balanced. Table 2 compares the sexes regarding their health behaviors and state of health as well as physiological protection factors and risk factors. Women followed a healthier diet, smoked less, and perceived their state of health as worse than did men. Measured concentrations for total cholesterol, LDL cholesterol, and HDL cholesterol in women were higher than in men.
Response rate—The response rate for the questionnaires was 98% (n = 534) at T1, 96% (n = 523) at T2, 82.9% (n = 452) at T3, and 77.2% (n = 421) at T4. No important differences were seen in terms of which study arm dropped-out participants came from (p = 0.19). Figure 2 shows the flow of participants through the study.
Follow-up analyses—For the primary endpoints physical activity (exercise behavior), dietary/nutritional habits, current subjective state of health, and medication adherence, no effects were found for the intervention (Table 3, eTable 1). Regarding changes to smoking status, no model calculations were possible owing to the low number of smokers; for this reason, relevant conclusions about the effectiveness of the intervention cannot be drawn with regard to smoking.
Exercise behavior in everyday life increased over the entire observation period in all study groups.
Dietary/nutritional habits and subjective state of health also improved over the entire study period and in all three study arms. For medication adherence, no substantial change was seen in the study groups between T3 and T4.
The proportion of smokers fell across groups from 12.4% (n = 66) at T1 to 8.6% (n = 36) at T4 (χ2=5.74, p = 0.017, df = 1) (data not shown).
Similarly, no effects were observed for the intervention for the secondary endpoints (blood pressure; blood glucose; total, LDL, and HDL cholesterol; HbA1c; and body mass index) over the study period.
Total cholesterol concentrations fell significantly in all study groups during the period of the rehabilitation measure (from T1 to T2) (p<0.001). They rose after the rehabilitation measure had ended, but they remained below the baseline measurement at T1. Crucial differences between the sexes were seen for the development of total cholesterol (χ2 = 41.09, p<0.001, df = 12). These resulted mainly from the higher values in women that already existed at T1. LDL cholesterol also fell in all study groups during the rehabilitation program (p<0.001). Subsequently LDL levels rose again but at T4 remained below the level at T1. HDL cholesterol concentrations rose in all study arms after the end of the rehabilitation measure. At T4 they were significantly above the baseline level (p<0.001). Differences between the sexes reached significance (χ2 = 104.54, p<0.001, df = 12). HDL values in women were higher than in men at all measuring points and resulted from the higher baseline level in women (data not shown).
Subgroup analyses—The comparison between the sexes with regard to the primary endpoints showed gender-specific differences in the subgroup analyses. In women in employment (n = 100) there were indications that the intervention potentially affected their physical activity if they had participated in a heart group. Furthermore, women in IGb displayed improved behavior regarding physical activity in everyday life at T4 (eTable 2). In non-working men, we saw indications of improved behaviors in terms of physical exercise at T4 (IGa and IGb) (eTable 3).
In terms of dietary habits, men and women differed clearly at all follow-up points (χ2 = 58.57, p<0.001, df = 9). Women followed better diets than men. In terms of subjective state of health and adherence to medication, no gender-specific differences were seen (χ2 = 8.95, p = 0.44, df = 9 and χ2 = 4.07, p = 0.67, df = 6, respectively) over time (data not shown).
The present study investigated whether goal setting undertaken by rehabilitation patients with coronary heart disease and their treating physicians at the end of the rehabilitation measure had an effect on cardiac risk factors during phase III of the rehabilitation.
As far as the primary endpoints physical activity, diet/nutrition, tobacco consumption, subjective state of health, and medication adherence, as well as the secondary result parameters (physiological protection factors and risk factors) are concerned, no differences were confirmed between the three study groups. The risk factors lack of exercise, unhealthy diet/nutrition, and smoking improved over the entire time, but no benefit was confirmed for the actual intervention. The smoking rate across the study groups fell from 12.4% initially to 8.6% after a year.
Exploratory subgroup analyses showed indications of positive effects (some 0.3 points) regarding improved exercise behavior in everyday life. These effects are to be interpreted as slight (22). Especially women in employment were able to increase their physical activity. Furthermore, participation in a heart group had a positive effect on women’s exercise behavior. A gender-specific subgroup effect was also seen for non-working rehabilitation patients. Men improved their physical activity. The background of this observation may be that men who are not in employment strongly internalize the information provided about the importance of physical exercise during the goal setting and goal checking sessions and then proceed to put this into practice.
In recent years, numerous intervention measures have been conducted to reduce existing risk factors in phase III rehabilitation (4–13). Self-regulation techniques—such as setting behavior-related goals, self control, time planning, and feedback techniques—provide valuable tools to this end (23–25). In the present study, a complex approach was followed in order to set goals for behavioral and physiological protection factors and risk factors in the rehabilitation setting, document these in writing, and refresh them three months after the end of the rehabilitation measure. Special attention was given to the consideration of gender-specific aspects. Efficacy studies with a concept such as this have thus far not been described in the literature, and for this reason it is not possible to compare results. An international review article by Ferrier et al. (26) showed—at least for the area of physical activity—the effectiveness of a collaborative approach between therapist and cardiological rehabilitation patient, in which specific goals are set in a motivational interview. However, our study did not confirm this effect.
In conducting the study, it was not possible in most institutions to use one doctor for participants in the intervention groups only and another in the control group. As the goal setting took place in the discharge consultation, treatment diffusion is a possibility, of which rehabilitation patients in the control group might have benefitted. The effects of the intervention measure are therefore rather likely to have been underestimated. Since the collection of interview data is based on self-reports from the rehabilitation patients, socially desirable responding behavior cannot be ruled out. This would, however, affect all three arms of the study and would therefore not systematically bias the results when comparing the groups. As in all intervention studies, it needs to be borne in mind that the calculation of case numbers was oriented exclusively to the primary endpoints. Analyses of secondary endpoints or subgroups are merely explorative and require affirmation in confirmatory studies. An additional limit is the fact that no data were collected regarding mortality or further cardiac events.
The efficacy of the intervention presented in this article, whereby goals were set jointly by doctors and patients at the end of a rehabilitation measure, and were refreshed three months later, was not shown in terms of the primary and secondary endpoints. The indications for a possibly beneficial effect on exercise behaviors among women in employment and non-employed men will have to be investigated in further studies. The implementation of this concept in routine clinical practice can therefore not be concluded from these results.
We thank the doctors and patients who participated in the quantitative study phase: Dr. med. Christoph Altmann (MEDIAN Gesundheitspark Bad Gottleuba), Dr. med. Hildegard Bollwein (formerly Klinik Höhenried, Bernried), Volkmar Dietzel (MEDIAN Gesundheitspark Bad Gottleuba), Dr. med. Waltraud Fahrig (formerly Ambulantes Rehabilitationszentrum Hubertus, Berlin), Dr. med. Hermann Fischer (Zentrum für ambulante Rehabilitation Herz & Kreislauf, Dresden), Dr. med. Stefan Grosche (Klinikzentrum Mühlengrund, Bad Wildungen), Dr. med. Heike Hafemann-Gietzen (formerly Frankenklinik Campus Bad Neustadt), Annett Hlousek (MEDIAN Gesundheitspark Bad Gottleuba), Dr. med. Britta Humann (herzhaus Berlin), Dr. med. Ute Kober (Klinikzentrum Mühlengrund, Bad Wildungen), Diethelm Neetz (formerly RehaCentrum Hamburg), Dr. med. Sabine Nitsche (Rehazentrum Westend, Berlin), Dr. med. Sieglinde Spörl-Dönch (Frankenklinik Campus Bad Neustadt). During the qualitative study phase we received support from patients and staff at the following centers, for which we express our thanks: Reha-Zentrum Seehof, Teltow; Vivantes Rehabilitation GmbH, Berlin; Strandklinik Boltenhagen; herzhaus, Berlin; Ambulantes Rehabilitationszentrum Hubertus, Berlin; MEDIAN Gesundheitspark, Bad Gottleuba; Rehazentrum Rankestraße, Berlin; Zentrum für ambulante Rehabilitation Herz & Kreislauf, Dresden.
The study was funded by the German Federal Pension Insurance
[Deutsche Rentenversicherung Bund] (funding reference 0421-FSCP-Z100).
Conflict of interest statement
The authors declare that no conflict of interest exists.
Manuscript received on 10 December 2015, revised version accepted on 18 April 2016.
Translated from the original German by Birte Twisselmann, PhD.
Dr. med. Sabine Stamm-Balderjahn, MPH
Institut für Medizinische Soziologie und Rehabilitationswissenschaft
Luisenstr. 13 A,
10117 Berlin, Germany
For eReferences please refer to:
Klinik Höhenried, Rehabilitationszentrum am Starnberger See, Bernried: Dr. med. Bongarth
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