Mountain Gail A, Hind Daniel, Gossage-Worrall Rebecca, Walters Stephen J, Duncan Rosie, Newbould Louise, Rex Saleema, Jones Carys, Bowling Ann, Cattan Mima, Cairns Angela, Cooper Cindy, Edwards Rhiannon Tudor, Goyder Elizabeth C
Clinical Trials Research Unit, ScHARR, University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK.
Trials. 2014 Apr 24;15:141. doi: 10.1186/1745-6215-15-141.
Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention.
Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation.
We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16).
Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre, and/or involve dedicated management of volunteers.
ISRCTN28645428.
老年人的孤独感与健康相关生活质量（HRQoL）较差有关。我们进行了一项平行组随机对照试验，以评估电话交友对维持老年人HRQoL的有效性和成本效益。一项内部预试验测试了该试验和干预措施的可行性。
通过全科医疗及其他渠道招募年龄大于74岁、认知功能良好、独立生活在英国一个城市的参与者，然后将其随机分为：（1）接受6周一对一短程电话交流，随后由一名经过培训的志愿者引导员带领进行为期12周、每组最多6名参与者的小组电话交流；或（2）对照组。主要试验要求在1年的招募期内招募248名参与者，其中124名接受电话交友服务。预试验规定了三个必须满足的成功标准，以便主要试验能够顺利完成：在95天内招募68名参与者；6个月时保留80%的参与者；全国性慈善机构的当地分支机构成功提供电话交友服务。主要临床结局是随机分组6个月后通过电话收集的简短健康调查问卷（SF-36）心理健康（MH）维度得分。
我们向9579名老年人介绍了这项研究。70名同意参与的参与者在95天内被随机分配到预试验组，其中56名（80%）提供了有效的主要结局数据（26名干预组，30名对照组）。由于志愿者引导员招募和留存情况不佳，随机分配到研究组的24名参与者实际接受了电话交友服务。因此，试验提前结束。干预组和对照组6个月时SF-36 MH维度的平均得分分别为78（标准差18）和71（标准差21）（平均差值为7；95%置信区间为-3至16）。
在1年的招募期内为确定性试验招募和留存参与者是可行的。对于志愿部门而言，要招募足够的志愿者以满足试验招募所产生的电话交友需求，该研究需要在多个主要人口中心开展，和/或涉及对志愿者的专门管理。
ISRCTN28645428
