De Wit, M., Delemarre-van de Waal, H., Bokma, J., Haasnoot, K., Houdijk, M., Gemke, R., et al. (2008). Monitoring and discussing the health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: A randomized controlled trial. Diabetes Care, 31(8), 1521-1527.
The paper sought to assess whether, in adolescents with type 1 diabetes, systemic control, monitoring and control of HRQoL (health-related quality of life) influence psychosocial wellbeing.
Health Outcome of Interest
Psychosocial wellbeing of adolescents with type I diabetes
Exposure(s) of Interest
Control and monitoring of HRQoL (health-related quality of life)
Types of Experimental Study
Depending on the classification by Aschengrau & Seage (2008), experimental studies employed could be individual, parallel and simple experimental studies.
Inclusion/Exclusion Criteria and Initial Sample Size in Each Arm
Exclusion criteria for this study were that the participants were to have had diabetes for more than 6 months, have no mental retardation, and be fluent in the Dutch language. Initially, the monitoring group had 46 subjects whereas the control group had 45 subjects (De Wit. & et al., 2008).
Data Collection at Baseline
Data collection was done through standardized questionnaires done thrice in a period of 12 months. Both groups lost members (five from each group) in the course of the study, with the losses being attributed to relocation or lack of interest in the study. Assessment of compliance was not an issue in this study because the response to the questionnaire was based on individual perception and wellbeing, as opposed to pharmacological changes brought out by drugs (De Wit. & et al., 2008).
Blinding of Subjects and Use of Placebo
Single blinding was used on the control group whereby the patients or teenage respondents completed a lifestyle questionnaire as opposed to an HRQoL questionnaire, which was completed, by the HRQoL intervention group. This information was only privy to the physicians in the clinics and not the patients (De Wit. & et al., 2008).
Type of Data Analysis (intention to treat)
Paired t-test and Wilcoxon’s signed-rank test were performed. Moreover, ANOVA measures were also done in linear modeling using SPSS 14.0. Comparison of the effects of HRQoL intervention in the two groups was done based on physical and psychosocial well-being, controlling for baseline levels and baseline characteristics
satisfaction with care, and glycemic control. Performing multi-linear regression analyses helped to eliminate the confounding effects of demographic variables and diabetes-related variables, thus allowing for a better comparison of the two groups (De Wit. & et al., 2008).
Results/Main Findings of Study
There were no significant differences between the two groups studied, in terms of glycemic control, diabetes, sex and age. However, adolescents in the treatment group reported significantly fewer behavioral problems than the control group, after a year of the study and during the follow-up. Similarly, the intervention group’s mental health and self-esteem significantly improved compared to the control group, an observation reinforced by their increased engagement in family and social activities (De Wit. & et al., 2008).
Comments (including generalizability of the study)
The study was quite successful in showing the connection between HRQoL intervention and the psychosocial well-being of adolescents with type I diabetes. However, the study was also hampered by several challenges which could limit the generalizability of the study (De Wit. & et al., 2008). Firstly, the sample population was quite small which according to Tulchinsky & Varavikova (2009) is attributed to the reluctance of diabetic patients to participate in clinical trials. Secondly, self-care behavior was not assessed which could have affected the eventual outcome of the study. Besides these, Aschengrau & Seage (2008) are of the opinion that more tests are needed to ascertain whether the outcome would be the same for less frequent monitoring of HRQoL interventions in diabetic adolescent patients.
Aschengrau, A. & Seage, G. (2008). Essentials of epidemiology in public health. New York: Jones & Bartlett Publishers.
De Wit, M., Delemarre-van de Waal, H., Bokma, J., Haasnoot, K., Houdijk, M., Gemke, R., et al. (2008). Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: A randomized controlled trial. Diabetes Care, 31(8), 1521-1527.
Tulchinsky, T.H & Varavikova, E. (2009). The new public health. New York: Academic Press