Clinical trial NCT04077229: Piloting Text Messages to Promote Positive Affect and Physical Activity
Official title: Piloting Text Messages to Promote Positive Affect and Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: ACS
Text Message
Positive Psychology
Health Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Ability to receive text messages via cellular phone.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of text messages successfully delivered to participants
timeFrame: 4 weeks
measure: Participant burden
timeFrame: 4 weeks
measure: Self-reported utility of the intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in Positive Affect at 4 weeks
timeFrame: Change in positive affect from baseline to 4 weeks
measure: Change in Positive Affect at 8 weeks
timeFrame: Change in positive affect from baseline to 8 weeks
measure: Change in Optimism at 4 weeks
timeFrame: Change in optimism from baseline to 4 weeks
measure: Change in Optimism at 8 weeks
timeFrame: Change in optimism from baseline to 8 weeks
measure: Change in Determination at 4 weeks
timeFrame: Change in determination from baseline to 4 weeks
measure: Change in Determination at 8 weeks
timeFrame: Change in determination from baseline to 8 weeks
measure: Change in Depression at 4 weeks
timeFrame: Change in depression from baseline to 4 weeks
measure: Change in Depression at 8 weeks
timeFrame: Change in depression from baseline to 8 weeks
measure: Change in Anxiety at 4 weeks
timeFrame: Change in anxiety from baseline to 4 weeks
measure: Change in Anxiety at 8 weeks
timeFrame: Change in anxiety from baseline to 8 weeks
measure: Change in Self-reported physical activity at 4 weeks
timeFrame: Change in self-reported physical activity from baseline to 4 weeks
measure: Change in Self-reported physical activity at 8 weeks
timeFrame: Change in self-reported physical activity from baseline to 8 weeks
measure: Change in Self-reported dietary adherence at 4 weeks
timeFrame: Change in dietary adherence from baseline to 4 weeks
measure: Change in Self-reported dietary adherence at 8 weeks
timeFrame: Change in dietary adherence from baseline to 8 weeks
measure: Change in Self-reported health/function at 4 weeks
timeFrame: Change in self-reported health/function from baseline to 4 weeks
measure: Change in Self-reported health/function at 8 weeks
timeFrame: Change in self-reported health/function from baseline to 8 weeks
measure: Change in self-reported physical function at 4 weeks
timeFrame: Change in self-reported physical function from baseline to 4 weeks
measure: Change in self-reported physical function at 8 weeks
timeFrame: Change in self-reported physical function from baseline to 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Jeff Huffman
state: Massachusetts
Study officials:
References: