Madueño Caro Antonio José, Mellado Fernández Manuel Luis, Pardos Lafarga Manuel, Muñoz Ayllón Marta, Martín-López Cristina, Gómez-Salgado Juan
Centro de salud La Laguna. Distrito Sanitario Cádiz Bahía La Janda. Cádiz. España.
Centro de salud Casines. Distrito Sanitario Cádiz Bahía La Janda. Cádiz. España.
Rev Esp Salud Publica. 2019 Jul 19;93:e201907046.
The literature points to the possibility of carrying out an intervention, from primary prevention to rehabilitation after a cardiac event, towards decreasing the incidence of such cardiac events and facilitating the return to daily life. The objective was to determine the effect of a cardiac rehabilitation intervention over perceived selfefficacy for patients who have suffered a cardiac event.
A community clinical trial, open, controlled, and randomised, was designed, and performed in primary care. To determine the sample size, the research team used the General Self-Efficacy Scale by Baessler and Schwarzer. The mean difference between groups considered of clinical relevance was of at least 6 points in the aforementioned General Self-Efficacy Scale. A precision of 95% and a test power of 80% were accepted. The result proposed a sample of 44 subjects in each group. Over 12 months, all subjects of legal age (N = 104), both sexes, that had concluded phase II in the cardiac rehabilitation unit of the university Hospital Puerta del Mar (Cadiz) were offered to participate in the study. The patients were informed about the study development, asking for their participation and providing them with a written informed consent. The subjects were randomly assigned to the intervention or control group through blind allocation (in a sealed envelope to the researcher), on a pre-set 2:1 ratio (two patients assigned to the intervention group to one assigned to the control group). A non-response or rejection to participate in the study record was made for the non-response analysis.
A total of 89 subjects were included in the statistical analysis (response rate of 85.57%), with an average age of 63.01 years (SD: 8.75). The main dependent variable was the scores difference between groups, comparing means before and after the intervention, through the General Self-Efficacy Scale by Baessler & Schwarner. A mean difference of 6.0972 points was obtained between the intervention and the control groups (p<0.0053; 95% CI -4.1950 to -10.29), as a result of a 3.3750 mean points increase (standard deviation: 7.01) in the intervention group and a 3.3750 mean points decrease (standard deviation: 7.19) in the control group. In relation to the possible changes to be detected through the Hamilton anxiety scale and the Beck's depression inventory, after finishing the intervention, an estimate and contrast of population means was made between groups for the scores difference in the Hamilton scale, determined on the final visit, with no significant differences found (t-student 0.1211; p <0.9 43). Similarly, no significant differences were found between the groups for the means obtained in the variable "Beck's depression inventory scores difference" (t-student -0.1281; p<0.8987).
The inclusion in cardiac rehabilitation programmes carried out in primary care improves the general perceived self-efficacy of patients who have suffered cardiac events.
文献指出,从一级预防到心脏事件后的康复进行干预,有可能降低此类心脏事件的发生率,并促进患者恢复日常生活。目的是确定心脏康复干预对发生过心脏事件的患者自我效能感的影响。
设计并在初级保健机构开展了一项开放性、对照性随机社区临床试验。为确定样本量,研究团队使用了贝斯勒和施瓦泽的一般自我效能量表。上述一般自我效能量表中具有临床相关性的组间平均差异至少为6分。接受95%的精确度和80%的检验效能。结果每组建议样本量为44名受试者。在12个月的时间里,向所有达到法定年龄(N = 104)、男女不限、已在加的斯市马尔港大学医院心脏康复科完成第二阶段治疗的患者提供参与本研究的机会。向患者告知研究进展,邀请他们参与并提供书面知情同意书。通过盲法分配(放入密封信封交给研究者),按照预设的2:1比例(两名患者分配到干预组,一名患者分配到对照组)将受试者随机分配到干预组或对照组。对不参与研究记录的情况进行无应答分析。
共有89名受试者纳入统计分析(应答率为85.57%),平均年龄为63.01岁(标准差:8.75)。主要因变量是组间得分差异,通过贝斯勒和施瓦纳的一般自我效能量表比较干预前后的均值。干预组和对照组之间的平均差异为6.0972分(p<0.0053;95%置信区间 -4.1950至-10.29),干预组平均得分增加3.3750分(标准差:7.01),对照组平均得分下降3.3750分(标准差:7.19)。关于通过汉密尔顿焦虑量表和贝克抑郁量表可能检测到的变化,干预结束后,对末次访视时汉密尔顿量表得分差异的组间总体均值进行了估计和对比,未发现显著差异(t检验值0.1211;p <0.943)。同样,在变量“贝克抑郁量表得分差异”的组间均值中也未发现显著差异(t检验值 -0.1281;p<0.8987)。
纳入初级保健机构开展的心脏康复项目可提高发生过心脏事件患者的总体自我效能感。