Methods used to maintain a high level of participant involvement in a clinical trial.

OBJECTIVES

To describe the strategies adopted to maintain high level participation throughout a community based clinical trial, and the reasons given by participants for why they participated in the study.

DESIGN

Observational study.

SETTING

Community based clinical trial in Melbourne, Australia that ran for 68 weeks and involved 2811 community based individuals from 600 families. A high level of commitment was required of the families; each participant completed a Health Diary each week of the 68 week study, as well as answering numerous other questionnaires, and providing faecal and blood samples.

MAIN RESULTS

Only 41 of the 600 families withdrew from the study; the majority of these families withdrew because they sold their home and moved from the study area. The completion rate of Health Diaries averaged 90.7% over the 68 weeks of data collection. Of the 559 families who completed the study, 524 (93.7%) completed the Participation Questionnaire. The statement that received the highest rating for why families enrolled in the study was they thought the study was researching an important community issue. The statements that received the highest ratings for why families continued to participate in the study was the family being kept well informed about the study's progress and that the study was well run.

CONCLUSIONS

The low numbers of withdrawals and the high level of participation throughout the study suggests the strategies of (a) having a non-aggressive recruitment method, (b) maintaining regular contact with the participants and (c) ensuring participants were kept well informed of the study's progress and constantly encouraged to continue participation were successful. The results also suggest people involve themselves in research because they perceive it to be of value to the community, not simply for personal gain. They indicated that they maintained their participation because it was a well run study and they were kept well informed throughout the study.