Experimental Study Designs
Research Question
Are there differences in satisfaction levels of adolescents suffering from type1 diabetes and receiving usual care and those suffering from the same condition but receiving systematic HRQoL intervention?
Health Outcomes of Interest
- Improving health-related quality of life (HRQoL) in adolescents suffering from type1 diabetes;
- Establishing if HRQoL intervention provides better care for adolescents with type1 diabetes (Maartje, Waal, Delemarre-van, Alle, Krijn, & Mieke, 2008).
Exposures of Interest
- Usual care for adolescents with type1 diabetes;
- Systematic HRQoL intervention for adolescents with type1 diabetes (Maartje, Waal, Delemarre-van, Alle, Krijn, & Mieke, 2008).
Type of Experimental Research Design
The study utilized three experimental research designs that included therapeutic experimental design (treatment was given to improve health-related quality of life); parallel experimental design (each of the two groups received a different treatment, and the treatments were administered concurrently); and simple experimental design (each group was provided with one treatment).
Inclusion/Exclusion Criteria and the Initial Sample Size in Each Arm
The Inclusion/exclusion criteria required the participants to be adolescents, suffering from type1 diabetes and be residents of the area under the study. The HRQoL intervention group had 46 subjects while the control group had 45 subjects (Maartje, Waal, Delemarre-van, Alle, Krijn, & Mieke, 2008).
Data Collection at Baseline
Data collection was facilitated by the following baseline requirements:
- Adolescents were to be suffering from type1 diabetes for a given duration;
- Comparative treatment regimens were implemented;
- Attendance of the four randomly assigned outpatient clinics was necessary;
- Physical and psychological measurements were assessed using the 87-item child health report questionnaire to establish a patient’s eligibility;
- Depressive symptomatology was defined using the 20-item Center for Epidemiological Studies Scale for Depression (CES-ED)(Bailey, 2008).
Blinding of Subjects and Use of Placebo
Blinding was achieved by providing normal conditions, such as utilizing contemporary clinical environment and employing normal assessment techniques
Type of Data Analysis
Data was collected using the following tools: Center for Epidemiological Studies Scale for Depression (CES-ED), to determine depressive symptomatology in the subjects; The Patient’s Evaluation of Quality of Diabetes Care (PEQ-D); The Pediatric Quality of Life Inventory (PedsQL), to establish HRQoL; Child Health Questionnaire (CHQ-CF87), to determine the physical and emotional well-being.
Statistical data analysis was done by Paired t-test or Wilcoxon to conduct follow-up studies on the change in baseline scores. Repeated measures ANOVA were obtained using SPSS 14.0 (Bailey, 2008).
Results and Main Findings of the Study
The findings of the study were as follows. The average score on the CHQ subscales of psychosocial health was P < 0.001, the behavior was P < 0.001, mental health was P < 0.001; and family activity at P < 0.001 was seen to improve in the HRQoL intervention group, except for the patients with the highest A1C scores (Maartje, Waal, Delemarre-van, Alle, Krijn, & Mieke, 2008). The HRQoL group also reported higher levels of self-esteem (CHQ) in the follow-up assessment (P=0.016), irrespective of the A1C values, and were more satisfied with the care provided (P= 0.009) as compared to the control subjects. No significant differences were observed between the control and the HRQoL groups (Maartje, Waal, Delemarre-van, Alle, Krijn, & Mieke, 2008).
The findings of the study indicate that the physical and psychological wellbeing of adolescents suffering from type1 diabetes can be improved significantly using the HRQoL strategies.
Comments (Including Generalizability of the Study)
The study has revealed that improvements in the quality of care offered to adolescents suffering from type1 diabetes could contribute to improving their physical and mental wellbeing. The findings of this study could inform researchers of other health conditions with similar effects on adolescents. If that is done, then the quality of life regarding the health of individuals suffering from such long-term diseases will be greatly improved.
References
Bailey, R. A. (2008). Design of Comparative Experiments. Cambridge: Cambridge University Press.
Maartje, D. W., Waal, D., Delemarre-van, H., Alle, B. J., Krijn, H., & Mieke, H. (2008). Monitoring and Discussing Health-Related Quality of life in Adolescents with Type 1 diabetes Improve Psychological Well-Being: A randomized controlled trial. Diabetes Care, 8,1521-6.