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351 PWD living in residential care facilities (PWD-RCF), their family carers and staff informants participated in the present baseline data collection of the DIRECT study, a randomised controlled trial of educational interventions aiming to improve the QoL of PWD living in RCF (the protocol details have been described elsewhere[9]).
The study design and protocol of baseline data collection of the cohort study were described previously (15).
The baseline data collection of lifestyle factors took place as planned with the exception of the technical problems reported above.
Detailed descriptions of study design, population, and baseline data collection of the cohort can be found elsewhere (Haftenberger et al, 2002; Riboli et al, 2002).
Eligible participants will be randomised following baseline data collection of primary and secondary outcome measures to receive either unloading shoes or control shoes.
Combined with the recruitment delay this meant that 18 months lapsed between the enrollment and baseline data collection of the first and last groups.
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A single round of mass administration of azithromycin was offered following baseline data collection to all residents of communities participating in these studies.
The interviews were conducted as part of the baseline data collection for the African Health Markets for Equity (AHME) qualitative evaluation.
Of those providing consent, 501 (91.1 %) completed baseline data collection (87.4%% of the 572 included men).
Patients who are deemed appropriate for enrolment into the study will be randomised, following completion of the baseline data collection and confirmation of eligibility, to one of two trial arms control (StanC) or treatment (PREHAB).
Unable to blind patients or physicians, we are using the techniques of baseline data collection before randomization, automation of outcome assessment, and blinding of the data analysis to decrease observer and assessment bias.
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