Research group on Global Health and Human Development, University of the Balearic Islands (UIB), Palma, Spain.
Health Research Institute of the Balearic Islands (IdISBa), Palma, Spain.
J Adv Nurs. 2021 Jul;77(7):3204-3217. doi: 10.1111/jan.14842. Epub 2021 Mar 26.
To evaluate the effectiveness of a nurse-led personalized telephone lifestyle intervention versus automated SMSs in the reduction of fasting plasma glucose in adults with prediabetes.
The PREDIPHONE is a randomized controlled, parallel, two arms, superiority trial with 15 months of follow-up. Participants will be randomized to either the intervention group (teleconsultations) or the active control group (SMSs).
A total of 428 participants will be randomized in a 1:1 ratio to one of the two arms and followed up during 9 months. The teleconsultations group will receive nurse-led personalized advice, while the SMSs group will receive 4-5 brief SMSs a week. Participants in both groups will receive evidence-based recommendations for diet and physical activity (PA). Outcome measures will be collected at baseline, months 4 and 9 and at month 15, to evaluate post-intervention effects.
Prevention of diabetes through the implementation of lifestyle interventions remains an important priority. The current pandemic situation has magnified its urgency as it heavily affected the functionality of the healthcare system. Moreover, it created the need of remotely delivering preventative interventions. This study will provide insights on the effectiveness and feasibility of a telephone-based intervention led by nurses in the amelioration of risk factors associated with diabetes.
Findings from this study will offer health services decision-makers sound evidence regarding an alternative method to face-to-face consultations that could be practical, acceptable and inexpensive, and that concretely answers the need for easily implementable prevention strategies.
NCT04735640 (ClinicalTrials.gov identifier).
V1.0, 18/02/2021.
评估护士主导的个性化电话生活方式干预与自动化短信在降低糖尿病前期成年人空腹血糖方面的效果。
PREDIPHONE 是一项随机对照、平行、双臂、优效性试验，随访时间为 15 个月。参与者将被随机分配到干预组（电话咨询）或对照组（短信）。
共有 428 名参与者将以 1:1 的比例随机分配到两个组中的一个，并在 9 个月内进行随访。电话咨询组将接受护士主导的个性化建议，而短信组将每周收到 4-5 条简短短信。两组参与者都将收到饮食和体力活动（PA）的循证建议。在基线、第 4 个月和第 9 个月以及第 15 个月收集结果测量值，以评估干预后的效果。
通过实施生活方式干预来预防糖尿病仍然是一个重要的优先事项。当前的大流行情况加剧了这种紧迫性，因为它严重影响了医疗保健系统的功能。此外，它还需要远程提供预防干预措施。这项研究将提供关于由护士主导的电话干预在改善与糖尿病相关的风险因素方面的有效性和可行性的见解。
这项研究的结果将为卫生服务决策者提供有关替代面对面咨询的方法的有力证据，这种方法可能是实际的、可接受的和廉价的，并且可以满足对易于实施的预防策略的需求。
NCT04735640（ClinicalTrials.gov 标识符）。
V1.0，2021 年 2 月 18 日。
