PDF(Pubmed)
Abstract：
BACKGROUND: A multi-component self-management intervention \'CFHealthHub\' was developed to reduce pulmonary exacerbations in adults with Cystic Fibrosis (CF) by supporting adherence to nebuliser medication. It was evaluated in a randomized controlled trial (RCT) involving 19 CF centres, with 32 interventionists, 305 participants in the intervention group, and 303 participants in the standard care arm. Ensuring treatment fidelity of intervention delivery was crucial to ensure that the intervention produced the expected outcomes.
METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform.
RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant.
CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care.
BACKGROUND: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).
METHODS: Fidelity of the CFHealthHub intervention and standard care was assessed using different methods for each of the five fidelity domains defined by the Borrelli framework: study design, training, treatment delivery, receipt, and enactment. Study design ensured that the groups received the intended intervention or standard care. Interventionists underwent training and competency assessments to be deemed certified to deliver the intervention. Audio-recorded intervention sessions were assessed for fidelity drift. Receipt was assessed by identifying whether participants set Action and Coping Plans, while enactment was assessed using click analytics on the CFHealthHub digital platform.
RESULTS: Design: There was reasonable agreement (74%, 226/305) between the expected versus actual intervention dose received by participants in the CFHealthHub intervention group. The standard care group did not include focused adherence support for most centres and participants. Training: All interventionists were trained. Treatment delivery: The trial demonstrated good fidelity (overall fidelity by centre ranged from 79 to 97%), with only one centre falling below the mean threshold (> 80%) on fidelity drift assessments. Receipt: Among participants who completed the 12-month intervention, 77% (205/265) completed at least one action plan, and 60% (160/265) completed at least one coping plan. Enactment: 88% (268/305) of participants used web/app click analytics outside the intervention sessions. The mean (SD) number of web/app click analytics per participant was 31.2 (58.9). Additionally, 64% (195/305) of participants agreed to receive notifications via the mobile application, with an average of 53.6 (14.9) notifications per participant.
CONCLUSIONS: The study demonstrates high fidelity throughout the RCT, and the CFHealthHub intervention was delivered as intended. This provides confidence that the results of the RCT are a valid reflection of the effectiveness of the CFHealthHub intervention compared to standard care.
BACKGROUND: ISRCTN registry: ISRCTN55504164 (date of registration: 12/10/2017).
摘要：
背景：开发了一种多组分自我管理干预措施“CFHealthHub”，以通过支持对雾化药物的依从性来减少患有囊性纤维化（CF）的成年人的肺部恶化。在一项涉及19个CF中心的随机对照试验（RCT）中进行了评估，有32位干预主义者，干预组的305名参与者，和303名标准护理组的参与者。确保干预措施交付的治疗保真度对于确保干预措施产生预期结果至关重要。
方法：对于Borrelli框架定义的五个保真度域中的每一个，使用不同的方法评估CFHealthHub干预和标准护理的保真度：研究设计，培训,治疗交付，收据,和制定。研究设计确保小组接受预期的干预或标准护理。干预人员接受了培训和能力评估，被认为是提供干预的认证。评估音频记录的干预会话的保真度漂移。通过确定参与者是否制定了行动和应对计划来评估收据，而制定是使用CFHealthHub数字平台上的点击分析进行评估的。
结果：设计：达成了合理的协议（74％，226/305）在CFHealthHub干预组参与者接受的预期干预剂量与实际干预剂量之间。标准护理组未包括对大多数中心和参与者的重点依从性支持。培训：所有干预人员都接受了培训。治疗交付：试验显示良好的保真度（中心的总体保真度范围为79％至97％），在保真度漂移评估中，只有一个中心低于平均阈值(>80%)。收据：在完成12个月干预的参与者中，77%(205/265)完成了至少一项行动计划，60%(160/265)完成了至少一项应对计划。制定：88％（268/305）的参与者在干预会议之外使用Web/应用程序点击分析。每位参与者的网络/应用程序点击分析平均（SD）数量为31.2（58.9）。此外,64%（195/305）的参与者同意通过移动应用程序接收通知，每个参与者平均收到53.6（14.9）个通知。
结论：该研究证明了整个RCT的高保真度，CFHealthHub干预措施按预期交付。与标准护理相比，RCT的结果有效反映了CFHealthHub干预的有效性。
背景：ISRCTN注册：ISRCTN55504164（注册日期：2017年12月10日）。
方法：对于Borrelli框架定义的五个保真度域中的每一个，使用不同的方法评估CFHealthHub干预和标准护理的保真度：研究设计，培训,治疗交付，收据,和制定。研究设计确保小组接受预期的干预或标准护理。干预人员接受了培训和能力评估，被认为是提供干预的认证。评估音频记录的干预会话的保真度漂移。通过确定参与者是否制定了行动和应对计划来评估收据，而制定是使用CFHealthHub数字平台上的点击分析进行评估的。
结果：设计：达成了合理的协议（74％，226/305）在CFHealthHub干预组参与者接受的预期干预剂量与实际干预剂量之间。标准护理组未包括对大多数中心和参与者的重点依从性支持。培训：所有干预人员都接受了培训。治疗交付：试验显示良好的保真度（中心的总体保真度范围为79％至97％），在保真度漂移评估中，只有一个中心低于平均阈值(>80%)。收据：在完成12个月干预的参与者中，77%(205/265)完成了至少一项行动计划，60%(160/265)完成了至少一项应对计划。制定：88％（268/305）的参与者在干预会议之外使用Web/应用程序点击分析。每位参与者的网络/应用程序点击分析平均（SD）数量为31.2（58.9）。此外,64%（195/305）的参与者同意通过移动应用程序接收通知，每个参与者平均收到53.6（14.9）个通知。
结论：该研究证明了整个RCT的高保真度，CFHealthHub干预措施按预期交付。与标准护理相比，RCT的结果有效反映了CFHealthHub干预的有效性。
背景：ISRCTN注册：ISRCTN55504164（注册日期：2017年12月10日）。
