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临床试验/NCT04077229
NCT04077229已完成不适用

Piloting Text Messages to Promote Positive Affect and Physical Activity

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Percentage of text messages successfully delivered to participants

研究概览

简要总结

The focus of the study is to assess the feasibility and acceptability of a pilot one-arm project delivering text messages related to positive psychology (PP) activities (e.g., recalling positive events) and health behavior text messages (e.g. having a heart-healthy diet, becoming more physically active). The messages will be sent for 4 weeks among patients with a prior acute coronary syndrome (ACS).

详细描述

This is a single-arm study of text messaging in post-ACS patients. The convenience sample for this pilot study will be enrolled from two sources: (a) participants prospectively enrolled from inpatient cardiac units at MGH admitted for an ACS, and (b) participants in prior post-ACS studies performed with the investigators' team.

A total of 28 intervention text messages (1/day for 4 weeks) will be sent to participants following the baseline assessment. After each message is sent, participants will receive a second text message asking them to rate the utility of the message, and this rating will be used by a machine learning algorithm to select subsequent messages. This will ensure that, over time, participants will receive messages that they are more likely to find useful.

In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and positive psychology messages. In the second part of the study, participants will receive 14 fixed text messages that range in topics from positive psychology to physical activity, diet, and medication adherence. In the second part of the study, participants will first receive a set of 14 pre-selected daily messages that contain a broad range of attributes to allow sufficient participant feedback to clearly identify preferences. After the first 14 messages, new messages will be selected based on the prior preferences of participants.

The messages will be sent using the Twilio texting program used by REDCap, which also uses Amazon Web Services. Twilio allows software developers to programmatically make and receive phone calls and send and receive text messages using its web service. The investigators have purchased a Twilio account to allow messages to come from an anonymous phone number rather than the phone of a study staff member.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Prior acute coronary syndrome.
  • Acute myocardial infarction (MI):
  • Elevation of cardiac biomarkers (cardiac troponin T) in addition to one or more of the following:
  • symptoms of ischemia (e.g., acute chest pain)
  • ischemic changes on electrocardiogram
  • imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
  • Unstable angina (UA):
  • crescendo angina
  • new onset (within 1 month) angina with minimal exertion
  • angina with minimal exertion or at rest.
  • Ability to receive text messages via cellular phone.

排除标准

  • A periprocedural ACS
  • Terminal illness
  • An unrelated condition limiting physical activity
  • An inability to communicate in English, or
  • cognitive disorder assessed by 6-item cognitive screen

结局指标

主要结局

Percentage of text messages successfully delivered to participants

时间窗: 4 weeks

Feasibility will be measured by calculating the percentage of text messages successfully delivered to participants.

Participant burden

时间窗: 4 weeks

Mean ratings of the intervention's burden, as reported by participants on a 0-10 Likert-type scale (0= not burdensome at all; 10= extremely burdensome).

Self-reported utility of the intervention

时间窗: 4 weeks

Mean ratings of the intervention's utility, as reported by participants on a 0-10 Likert-type scale (0= not helpful at all; 10= extremely helpful).

次要结局

  • Change in Determination at 4 weeks(Change in determination from baseline to 4 weeks)
  • Change in Positive Affect at 4 weeks(Change in positive affect from baseline to 4 weeks)
  • Change in Positive Affect at 8 weeks(Change in positive affect from baseline to 8 weeks)
  • Change in Optimism at 4 weeks(Change in optimism from baseline to 4 weeks)
  • Change in Optimism at 8 weeks(Change in optimism from baseline to 8 weeks)
  • Change in Determination at 8 weeks(Change in determination from baseline to 8 weeks)
  • Change in Depression at 4 weeks(Change in depression from baseline to 4 weeks)
  • Change in Depression at 8 weeks(Change in depression from baseline to 8 weeks)
  • Change in Anxiety at 4 weeks(Change in anxiety from baseline to 4 weeks)
  • Change in Anxiety at 8 weeks(Change in anxiety from baseline to 8 weeks)
  • Change in Self-reported physical activity at 4 weeks(Change in self-reported physical activity from baseline to 4 weeks)
  • Change in Self-reported physical activity at 8 weeks(Change in self-reported physical activity from baseline to 8 weeks)
  • Change in Self-reported dietary adherence at 4 weeks(Change in dietary adherence from baseline to 4 weeks)
  • Change in Self-reported dietary adherence at 8 weeks(Change in dietary adherence from baseline to 8 weeks)
  • Change in Self-reported health/function at 4 weeks(Change in self-reported health/function from baseline to 4 weeks)
  • Change in Self-reported health/function at 8 weeks(Change in self-reported health/function from baseline to 8 weeks)
  • Change in self-reported physical function at 4 weeks(Change in self-reported physical function from baseline to 4 weeks)
  • Change in self-reported physical function at 8 weeks(Change in self-reported physical function from baseline to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff C. Huffman, MD

Associate Professor of Psychiatry, Harvard Medical School

Massachusetts General Hospital

研究点 (2)

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