Piloting Text Messages to Promote Positive Affect and Physical Activity

NCT ID: NCT04077229

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-10-31

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

A total of 28 intervention text messages (1/day for 4 weeks) will be sent to participants following the baseline self-report assessment. After each message is sent, participants will receive a second text message asking them to rate the utility of the message. Following the 4-week intervention, participants will complete the same self-report assessments as in the baseline assessment (via phone) and will provide feedback about the program. Finally, 4 weeks later (at 8 weeks), participants will repeat the self-report questionnaires by phone.

Group Type: EXPERIMENTAL

Intervention arm: Text Message Intervention

Intervention Type: BEHAVIORAL

Participants will receive a combination of messages promoting both psychological well-being and education /support around health behavior adherence, such as physical activity or diet. In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and PP (Positive Psychology) messages. 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.

Interventions

Intervention arm: Text Message Intervention

Participants will receive a combination of messages promoting both psychological well-being and education /support around health behavior adherence, such as physical activity or diet. In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and PP (Positive Psychology) messages. 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Associate Professor of Psychiatry, Harvard Medical School

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jeff Huffman

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P001472

Identifier Type: -

Identifier Source: org_study_id