Effectiveness of an educational nursing intervention on caring ability and burden in family caregivers of patients with chronic non-communicable diseases. A preventive randomized controlled clinical trial
A preventive controlled clinical trial was conducted with two comparison groups (intervention and control) in 2017. The inclusion criteria were to be aged 18 or over, be the caregiver of a patient with a chronic non-communicable disease (NCD) and the time devoted to caring was at least three months. Caregivers with difficulties in communication and those who could not receive the whole intervention were excluded. To meet the selection criteria, 34 family caregivers of patients with NCD were selected, who were users of a private tertiary hospital in Bucaramanga (Colombia). Randomization. To assign the intervention, on behalf of the project coordination center, a co-researcher of this study randomized family caregivers in balanced blocks to either the control group or intervention group, by using a list of random numbers generated in Excel. Intervention. The intervention consisted of the application of a four-topic workshop aimed at improving the family caregiver ability on knowledge, courage and patience, using a booklet designed by the Universidad Nacional de Colombia. This workshop was individually applied to each patient in a window of 3 hours at the hospital and was led by a nurse of the research team accompanied by a final year student of the nursing degree. The topics, objectives and activities are described in Table 1. Training related to the chronic pathology was provided to the control group, using educational support material designed by the research team. All participants of the control group were offered to have an intervention after the post-intervention surveys had been applied.
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Procedure and Information Collection. The research team was responsible for the information collection (four nursing professionals, two of them hold a master’s degree in epidemiology and another one holds a postgraduate diploma in university teaching), with the collaboration of three students of the CUIDEN research seedbed group. All these people had prior training on the use of the instrument and the application of the intervention using the educational booklet “Caring for Caregivers”. Initially, hospitalized patients with chronic non-communicable diseases were identified at “Los Comuneros” University Hospital in Bucaramanga. Once the patient had been selected, the caregiver was identified to later define the objective, importance and procedures of the study. Then, the informed consent was signed and the instruments for the collection of sociodemographic information and the caring ability and burden assessment (pre-intervention) were filled out. Later, an educational workshop was carried out on the four topics of the “Caring for Caregivers” program to the intervention group. Likewise, an educational meeting on chronic diseases and their caring was carried out to the control group. Family caregivers were contacted on the next day to apply again the instruments of caring ability and burden assessment (postintervention). People who carried out the study assessments and the responsible person for the statistical analysis of the information did not know to which group the participant’s information belonged. It was not possible to mask the group allocation due to the nature of the intervention. The process carried out with the group participants is shown in Table 2. Information Analysis. The collected information was analyzed using the statistical software Stata14 (Stata Corporation, College Station, USA). Quantitative variables showed a nonparametric distribution, so the middle value and the interquartile range were reported. The Mann—Whitney U test was applied to identify differences among the groups (intervention and control groups). Relative and absolute frequencies were calculated for the categorical variables. Fisher’s exact test was also applied as cells had an expected value of less than 5. For all tests, when the reported probability value was less than 0.05, a statistical significance was assumed. To measure changes in scores of Zarit and CAI scales prior and after the intervention, the Wilcoxon signed-rank test was used for repeated measures in groups and the Mann—Whitney U test was used when assessing differences between groups.