Date Modified

2016-08-05

Period

6/months

Report Summary

Following approval of my protocol change (change of one study centre – Please see attached previous communication, annex A, on this matter) by Ethics Review Committee and Research and Higher Degrees Committee of Faculty of Medicine, Colombo, preparations were made for data collection from 30/11/2015. However, due to following reasons first patient was recruited on 13/01/2016: 1. Approval from Sri Lanka Clinical Trials Registry for protocol change was obtained by 03/12/2015. 2. Two of the study instruments (MMQa and MMQb) needed extensive training by staff in application as they were found to be too complicated during practical application. 3. Sluggishness in initiation of getting patients for recruitment until the potential referral parties (other wards, OPD etc) became familiar with the process of sending potential study participants. Relevant staff have been trained on recruitment and carrying out the treatments according to manual of the study protocol. Twelve participants have been recruited so far.

Attached file