An interventional study of Phone call intervention, no phone call intervention in Medication Adherence, sponsored by Baoshan Prefecture Center for Disease Control and Prevention. Status unknown at 4 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-18.
Sponsored by Baoshan Prefecture Center for Disease Control and Prevention · Not applicable, Interventional, and Treatment
The adherence rate (95%) to HAART in the intervention group which receives a phone call will be higher than that(75%)of control group which does not receive a phone call.
According to above eligibility criteria, getting two eligible group patients, one which are patients newly required HAART (new cases) and the other who have received HAART for 1-3 years(old cases). All eligible patients in each group will be randomly assigned to intervention and control group by block randomization. Among of them, one group with a phone call intervention, the other without. New cases will be followed up for 3 months and study outcomes will be assessed at the baseline and the 2nd week, the 1st month and 2nd month, and the 3rd month. For the old cases, study outcomes will be assessed only at the baseline survey and at the 3rd month.
This is the only study on the registry with Baoshan Prefecture Center for Disease Control and Prevention as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
New cases and old cases will be randomly categorized into two groups,respectively,one is phone call intervention group, the other is no phone call intervention group.
Behavioral: Phone call intervention, no phone call intervention
Biweekly phone call intervention +routine service will be assigned to intervention group of new cases and old cases. Only routine service will be assigned to the control group of abovementioned two kind of cases.
Change from baseline HAART adherence within 3 months
Adherence will be measured at different time points within 3 months follow-up (study period)
Time frame: HAART adherence for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases HAART adherence will be assessed only at the baseline survey and the 3rd month follow-up
Change from baseline quality of life within 3 months
Quality of life will be measured at different time points within 3 months study periods
Time frame: Quality of life for new cases will be assessed at the baseline survey and the 2nd week, the 1st month and 2nd month, and the 3rd month. For old cases quality of life will be assessed only at the baseline survey and the end of the 3rd month
CD4 cell counts
CD4 cell counts will be measured only at baseline survey and after 3 months
Time frame: CD4 will be measured at the baseline survey and the 3rd month follow-up
Number of patients with side effects
The number of side effects will be measured at different time points within 3 months follow-up period
Time frame: Number of side effects for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases the number of side effects will be assessed only at the baseline survey and the 3rd month follow-up
Number of opportunistic infection within 3 months
Number of opportunistic infection will be measured at different time points within 3 months follow-up period(study period)
Time frame: Number of opportunistic infection for new cases will be assessed at the 2nd week, the 1st month and 2nd month, and the 3rd month follow-up. For old cases number of that will be assessed only at the baseline and the 3rd month follow-up
Mortality
Measurement of the number of change of mortality
Time frame: Mortality will be assessed the 3rd month follow-up
This study is status unknown, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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