Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.
Comparing treatment fidelity between study arms of a randomized controlled clinical trial for stroke family caregivers.
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DOI：
10.1177/0269215515585134
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发表时间：
2016-05
影响因子：
3
通讯作者：
Bakas T
中科院分区：
文献类型：
--
作者：
McLennon SM;Hancock RD;Redelman K;Scarton LJ;Riley E;Sweeney B;Habermann B;Jessup NM;Bakas T
比较中风照顾者电话评估和技能培养工具包研究(任务II)中不同治疗方案的治疗忠诚度：1)遵守方案；2)干预剂量；3)护士干预者的观点。随机对照临床试验设计。城市，社区，美国中西部。254名卒中照顾者(平均年龄54.4±11.8岁)，55名(22.0%)男性和199名(78.4%)女性随机分为任务II干预组(n=123)或信息、支持和转介(ISR)对照组(n=131)。任务II参与者收到任务II资源指南；ISR参与者收到标准照顾者手册。在出院后大约8周，两组患者每周都会接到8次护士打来的电话，4周后再接到一次电话。使用TASK II《监测遵守情况检查表》对协议遵守情况进行评估。干预剂量是通过照顾者阅读材料和与护士交谈的分钟数来衡量的。护士干预者的观点通过焦点小组获得。任务II的协议遵从率为80%，ISR为92%。正如预期的那样，在照顾者阅读材料(t=−6.49；p<；.001)和与护士交谈(t=−7.38；p<；.001)所花费的时间方面，任务II和isr之间的干预剂量不同。由护士组成的焦点小组为治疗的忠诚度提供了进一步的证据，并为未来的试验提出了建议。这些发现证实了TASK II中风照顾者干预试验的两个研究分支的治疗保真度[NIH R01NR010388；临床试验。政府NCT01275495]。
To compare treatment fidelity among treatment arms in the Telephone Assessment and Skill-Building Kit study for stroke caregivers (TASK II) with respect to: 1) protocol adherence; 2) intervention dosage; and 3) nurse intervener perspectives. A randomized controlled clinical trial design. Urban, community, midwestern United States. 254 stroke caregivers (mean ± SD age, 54.4 ± 11.8 years), 55 (22.0%) males and 199 (78.4%) females) randomized to the TASK II intervention (n=123) or an Information, Support, and Referral (ISR) comparison group (n=131). TASK II participants received the TASK II Resource Guide; ISR participants received a standard caregiver brochure. At approximately 8 weeks after discharge, both groups received 8 weekly calls from a nurse, with a booster call 4 weeks later. Protocol adherence was evaluated with the TASK II Checklist for Monitoring Adherence. Intervention dosage was measured by the number of minutes caregivers spent reading materials and talking with the nurse. Nurse intervener perspectives were obtained through focus groups. Protocol adherence was 80% for the TASK II and 92% for the ISR. As expected, intervention dosage differed between TASK II and ISR with respect to caregiver time spent reading materials (t=−6.49; p<.001) and talking with the nurse (t=−7.38; p<.001). Focus groups with nurses yielded further evidence for treatment fidelity and recommendations for future trials. These findings substantiate treatment fidelity in both study arms of the TASK II stroke caregiver intervention trial [NIH R01NR010388; ClinicalTrials.govNCT01275495].