Methods: Women between 45-64 years old reporting symptoms of menopause and considering the use of NHP were randomised to the PDA (intervention group) or an information leaflet about the menopause (control group). We aimed to recruit 90 women in total through advertisements in health care sites and work places for a minimum of 70 women completing the study. Base line measures included decisional conflict using the decisional conflict scale, knowledge of NHPs, preference for a particular option and values important to the women in making a decision. The women were given a 2 weeks period to use to PDA. After this period the base line measures were repeated and the woman's intention to disclose their use of NHP to a physician was assessed. ANCOVA is used to assess the difference between both groups while controlling for baseline decisional conflict.
Results: A total of 90 women enrolled in the study. Interest in the study was high with recruitment taking only four weeks. Complete data are currently available for 19 women in the PDA group and 21 in the control group. At baseline, there were no difference between the PDA and control groups on socio demographic variables and on decisional conflict (2.54±0.85 and 2.47±0.67 respectively, p=0.77). Follow up data shows no statistically significant difference between the two groups on change in decisional conflict with using the PDA (p=0.30). However, the size of the reduction in decisional conflict in the PDA group appears to be larger than in the control group (-0.67±0.55, p<0.0001 and -0.54±0.87, p=0.0098 respectively).
Conclusions: Data collection will be complete by July 2006. Preliminary results suggest the PDA may reduce decisional conflict more than the information leaflet.