Miller Eliza G, Nowson Caryl A, Dunstan David W, Kerr Deborah A, Solah Vicky, Menzies David, Daly Robin M
Institute for Physical Activity and Nutrition, Deakin University, Geelong, VIC, Australia.
Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia.
Trials. 2016 Sep 26;17(1):467. doi: 10.1186/s13063-016-1589-5.
Recruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates associated with such recruitment. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT). A secondary aim is to assess the costs associated with the recruitment methods used.
The Resistance Exercise, Vitamin D and Muscle Protein Intervention Trial (REVAMP-IT) for type 2 diabetes is a 24-week RCT targeting 202 adults with type 2 diabetes which is designed to evaluate whether post-exercise ingestion of a whey- protein and vitamin D-enriched drink can enhance the effects of progressive resistance training (PRT) on glycaemic control, body composition and cardiometabolic health. Participants in this trial were randomly allocated to either: (1) the Lift for Life® community-based PRT program combined with additional whey protein and vitamin D, or (2) the Lift for Life® PRT program alone. Recruitment strategies included state and local newspaper and radio advertisements, targeted mail-outs, doctor and allied health referrals, community presentations, web-based media and word of mouth. The number of expressions of interest, participants screened and included in the trial, and how they first heard about the study were recorded by research staff during the screening process. Reasons for ineligibility or non-participation in the trial were also recorded as was the cost of each recruitment method used.
A total of 1157 expressions of interest were received over a 21-month recruitment period. Overall 959 (83 %) individuals were screened and found to be ineligible for the trial or chose not to participate or could not be contacted further following their initial enquiry. As a result, 198 participants were randomised to the 24-week intervention. The most effective recruitment strategies were targeted mass mail-outs (39 % of the total participant sample), state (27 %) and local (14 %) print media. In total recruitment expenditure was AUD$40,421, which equated to AUD$35 per enquiry and AUD$204 per eligible participant. Targeted mail-outs and state print media were the most expensive strategies each accounting for 38 % of total expenditure.
To recruit around 200 older adults with type 2 diabetes into a community-based lifestyle intervention trial in a timely manner, it is important to ensure that an adequate budget is allocated to recruitment as targeted mail-outs and state/local print media were the most costly but effective strategies.
Australian New Zealand Clinical Trials Registry reference ACTRN12613000592741 . Registered on 27 May 2013.
将参与者纳入长期的基于社区的生活方式干预试验,尤其是患有慢性病的成年人,往往进展缓慢且具有挑战性。目前,关于适合患有2型糖尿病的老年人参加基于社区的运动和营养项目的成功招募策略的数据有限,且没有关于此类招募相关成本估计的信息。本报告的目的是描述所采用的招募策略以及每种方法在将患有2型糖尿病的老年人招募到一项为期6个月的基于社区的运动和营养补充随机对照试验(RCT)中的成功情况。第二个目的是评估所采用的招募方法的相关成本。
2型糖尿病的抗阻运动、维生素D与肌肉蛋白干预试验(REVAMP - IT)是一项为期24周的RCT,目标是202名2型糖尿病成年人,旨在评估运动后摄入富含乳清蛋白和维生素D的饮料是否能增强渐进性抗阻训练(PRT)对血糖控制、身体成分和心脏代谢健康的影响。该试验的参与者被随机分配到以下两组之一:(1)基于社区的“为生活而举”PRT项目,同时补充额外的乳清蛋白和维生素D;(2)仅“为生活而举”PRT项目。招募策略包括州和地方报纸及广播广告、定向邮寄、医生和专职医疗人员推荐、社区宣讲、网络媒体以及口碑传播。研究人员在筛选过程中记录了感兴趣的表达数量、筛选并纳入试验的参与者数量,以及他们首次得知该研究的途径。还记录了不符合资格或不参与试验的原因以及所采用的每种招募方法的成本。
在为期21个月的招募期内,共收到1157份感兴趣的表达。总体而言,959名(83%)个体经筛选后被发现不符合试验资格、选择不参与或在初次询问后无法进一步联系。结果,198名参与者被随机分配到为期24周的干预组。最有效的招募策略是定向大规模邮寄(占总参与者样本的39%)、州(27%)和地方(14%)平面媒体。招募总支出为40421澳元,相当于每份询问35澳元,每名符合资格的参与者204澳元。定向邮寄和州平面媒体是最昂贵的策略,各占总支出的38%。
为了及时将约200名患有2型糖尿病的老年人招募到基于社区的生活方式干预试验中,确保为招募分配足够的预算很重要,因为定向邮寄和州/地方平面媒体是成本最高但最有效的策略。
澳大利亚新西兰临床试验注册中心编号ACTRN12613000592741。于2013年5月27日注册。