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Piloting Text Messages to Promote Positive Affect and Physical Activity

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention arm: Text Message Intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring ACS, Text Message, Positive Psychology, Health Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jeff Huffman

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Positive Affect at 4 weeks
Pre-post changes in level of positive affect on a 0-10 Likert scale (0=not happy at all, 10-extremely happy). Higher values represent a better outcome.
Change in Positive Affect at 8 weeks
Pre-post changes in level of positive affect on a 0-10 Likert scale (0=not happy at all, 10-extremely happy). Higher values represent a better outcome.
Change in Optimism at 4 weeks
Pre-post changes in level of optimism on a 0-10 Likert scale (0=not optimistic at all, 10-extremely optimistic). Higher values represent a better outcome.
Change in Optimism at 8 weeks
Pre-post changes in level of optimism on a 0-10 Likert scale (0=not optimistic at all, 10-extremely optimistic). Higher values represent a better outcome.
Change in Determination at 4 weeks
Pre-post changes in level of determination on a 0-10 Likert scale (0=not determined at all, 10= extremely determined). Higher values represent a better outcome.
Change in Determination at 8 weeks
Pre-post changes in level of determination on a 0-10 Likert scale (0=not determined at all, 10= extremely determined). Higher values represent a better outcome.
Change in Depression at 4 weeks
Pre-post changes in level of depression on a 0-10 Likert scale (0=not depressed at all, 10= extremely depressed). Higher values represent a better outcome.
Change in Depression at 8 weeks
Pre-post changes in level of depression on a 0-10 Likert scale (0=not depressed at all, 10= extremely depressed). Higher values represent a better outcome.
Change in Anxiety at 4 weeks
Pre-post changes in level of anxiety on a 0-10 Likert scale (0=not anxious at all, 10= extremely anxious). Higher values represent a better outcome.
Change in Anxiety at 8 weeks
Pre-post changes in level of anxiety on a 0-10 Likert scale (0=not anxious at all, 10= extremely anxious). Higher values represent a better outcome.
Change in Self-reported physical activity at 4 weeks
Pre-post changes in level of physical activity. Participants will complete a two-item assessment for physical activity that has been validated and used in thousands of patients in the Kaiser Permanente system. We will record completion of moderate activity in number of minutes of activity/week. The items are: In the past 4 weeks, how many days/week did you engage in moderate or greater physical activity? On those days, how many minutes do you engage in activity at this level? These two measures are multiplied to arrive at the average min/week of moderate or greater physical activity.
Change in Self-reported physical activity at 8 weeks
Pre-post changes in level of physical activity. Participants will complete a two-item assessment for physical activity that has been validated and used in thousands of patients in the Kaiser Permanente system. We will record completion of moderate activity in number of minutes of activity/week. The items are: In the past 4 weeks, how many days/week did you engage in moderate or greater physical activity? On those days, how many minutes do you engage in activity at this level? These two measures are multiplied to arrive at the average min/week of moderate or greater physical activity.
Change in Self-reported dietary adherence at 4 weeks
Pre-post changes in level of self-reported dietary adherence. Participants will be asked a single item about self-reported dietary adherence, adapted from the Medical Outcomes Study Specific Adherence Scale. "In the last month, how often have you followed a low-fat, low-salt, or other diet as prescribed by your treatment team?" Choices will include "None of the time (1)," "A little of the time (2)," "Some of the time (3)," "A good bit of the time (4)," "most of the time (5)," and "all of the time (6)." Higher values represent a better outcome.
Change in Self-reported dietary adherence at 8 weeks
Pre-post changes in level of self-reported dietary adherence. Participants will be asked a single item about self-reported dietary adherence, adapted from the Medical Outcomes Study Specific Adherence Scale. "In the last month, how often have you followed a low-fat, low-salt, or other diet as prescribed by your treatment team?" Choices will include "None of the time (1)," "A little of the time (2)," "Some of the time (3)," "A good bit of the time (4)," "most of the time (5)," and "all of the time (6)." Higher values represent a better outcome.
Change in Self-reported health/function at 4 weeks
Participants will be asked a single item about self-reported health: "In general, how would you rate your health today" with the possible choices being "very good" (1), "good" (2), "moderate" (3), "bad" (4) or "very bad" (5). This scale is a robust predictor of mortality and correlates strongly with other objective health indicators. Lower values represent a better outcome.
Change in Self-reported health/function at 8 weeks
Participants will be asked a single item about self-reported health: "In general, how would you rate your health today" with the possible choices being "very good" (1), "good" (2), "moderate" (3), "bad" (4) or "very bad" (5). This scale is a robust predictor of mortality and correlates strongly with other objective health indicators. Lower values represent a better outcome.
Change in self-reported physical function at 4 weeks
This will be assessed with the Duke Activity Status Index (DASI). The DASI contains 12 items that inquire about activities of daily living (e.g., bathing), basic physical activity (e.g., walking, climbing stairs), and more strenuous physical function (e.g., vigorous sports) to gauge overall functional capacity. Higher values represent a better outcome (range 0-58.2).
Change in self-reported physical function at 8 weeks
This will be assessed with the Duke Activity Status Index (DASI). The DASI contains 12 items that inquire about activities of daily living (e.g., bathing), basic physical activity (e.g., walking, climbing stairs), and more strenuous physical function (e.g., vigorous sports) to gauge overall functional capacity. Higher values represent a better outcome (range 0-58.2).

Full Information

First Posted
August 28, 2019
Last Updated
February 19, 2020
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04077229
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
ACS, Text Message, Positive Psychology, Health Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention arm: Text Message Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of text messages successfully delivered to participants
Description
Feasibility will be measured by calculating the percentage of text messages successfully delivered to participants.
Time Frame
4 weeks
Title
Participant burden
Description
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).
Time Frame
4 weeks
Title
Self-reported utility of the intervention
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Change in Positive Affect at 4 weeks
Description
Pre-post changes in level of positive affect on a 0-10 Likert scale (0=not happy at all, 10-extremely happy). Higher values represent a better outcome.
Time Frame
Change in positive affect from baseline to 4 weeks
Title
Change in Positive Affect at 8 weeks
Description
Pre-post changes in level of positive affect on a 0-10 Likert scale (0=not happy at all, 10-extremely happy). Higher values represent a better outcome.
Time Frame
Change in positive affect from baseline to 8 weeks
Title
Change in Optimism at 4 weeks
Description
Pre-post changes in level of optimism on a 0-10 Likert scale (0=not optimistic at all, 10-extremely optimistic). Higher values represent a better outcome.
Time Frame
Change in optimism from baseline to 4 weeks
Title
Change in Optimism at 8 weeks
Description
Pre-post changes in level of optimism on a 0-10 Likert scale (0=not optimistic at all, 10-extremely optimistic). Higher values represent a better outcome.
Time Frame
Change in optimism from baseline to 8 weeks
Title
Change in Determination at 4 weeks
Description
Pre-post changes in level of determination on a 0-10 Likert scale (0=not determined at all, 10= extremely determined). Higher values represent a better outcome.
Time Frame
Change in determination from baseline to 4 weeks
Title
Change in Determination at 8 weeks
Description
Pre-post changes in level of determination on a 0-10 Likert scale (0=not determined at all, 10= extremely determined). Higher values represent a better outcome.
Time Frame
Change in determination from baseline to 8 weeks
Title
Change in Depression at 4 weeks
Description
Pre-post changes in level of depression on a 0-10 Likert scale (0=not depressed at all, 10= extremely depressed). Higher values represent a better outcome.
Time Frame
Change in depression from baseline to 4 weeks
Title
Change in Depression at 8 weeks
Description
Pre-post changes in level of depression on a 0-10 Likert scale (0=not depressed at all, 10= extremely depressed). Higher values represent a better outcome.
Time Frame
Change in depression from baseline to 8 weeks
Title
Change in Anxiety at 4 weeks
Description
Pre-post changes in level of anxiety on a 0-10 Likert scale (0=not anxious at all, 10= extremely anxious). Higher values represent a better outcome.
Time Frame
Change in anxiety from baseline to 4 weeks
Title
Change in Anxiety at 8 weeks
Description
Pre-post changes in level of anxiety on a 0-10 Likert scale (0=not anxious at all, 10= extremely anxious). Higher values represent a better outcome.
Time Frame
Change in anxiety from baseline to 8 weeks
Title
Change in Self-reported physical activity at 4 weeks
Description
Pre-post changes in level of physical activity. Participants will complete a two-item assessment for physical activity that has been validated and used in thousands of patients in the Kaiser Permanente system. We will record completion of moderate activity in number of minutes of activity/week. The items are: In the past 4 weeks, how many days/week did you engage in moderate or greater physical activity? On those days, how many minutes do you engage in activity at this level? These two measures are multiplied to arrive at the average min/week of moderate or greater physical activity.
Time Frame
Change in self-reported physical activity from baseline to 4 weeks
Title
Change in Self-reported physical activity at 8 weeks
Description
Pre-post changes in level of physical activity. Participants will complete a two-item assessment for physical activity that has been validated and used in thousands of patients in the Kaiser Permanente system. We will record completion of moderate activity in number of minutes of activity/week. The items are: In the past 4 weeks, how many days/week did you engage in moderate or greater physical activity? On those days, how many minutes do you engage in activity at this level? These two measures are multiplied to arrive at the average min/week of moderate or greater physical activity.
Time Frame
Change in self-reported physical activity from baseline to 8 weeks
Title
Change in Self-reported dietary adherence at 4 weeks
Description
Pre-post changes in level of self-reported dietary adherence. Participants will be asked a single item about self-reported dietary adherence, adapted from the Medical Outcomes Study Specific Adherence Scale. "In the last month, how often have you followed a low-fat, low-salt, or other diet as prescribed by your treatment team?" Choices will include "None of the time (1)," "A little of the time (2)," "Some of the time (3)," "A good bit of the time (4)," "most of the time (5)," and "all of the time (6)." Higher values represent a better outcome.
Time Frame
Change in dietary adherence from baseline to 4 weeks
Title
Change in Self-reported dietary adherence at 8 weeks
Description
Pre-post changes in level of self-reported dietary adherence. Participants will be asked a single item about self-reported dietary adherence, adapted from the Medical Outcomes Study Specific Adherence Scale. "In the last month, how often have you followed a low-fat, low-salt, or other diet as prescribed by your treatment team?" Choices will include "None of the time (1)," "A little of the time (2)," "Some of the time (3)," "A good bit of the time (4)," "most of the time (5)," and "all of the time (6)." Higher values represent a better outcome.
Time Frame
Change in dietary adherence from baseline to 8 weeks
Title
Change in Self-reported health/function at 4 weeks
Description
Participants will be asked a single item about self-reported health: "In general, how would you rate your health today" with the possible choices being "very good" (1), "good" (2), "moderate" (3), "bad" (4) or "very bad" (5). This scale is a robust predictor of mortality and correlates strongly with other objective health indicators. Lower values represent a better outcome.
Time Frame
Change in self-reported health/function from baseline to 4 weeks
Title
Change in Self-reported health/function at 8 weeks
Description
Participants will be asked a single item about self-reported health: "In general, how would you rate your health today" with the possible choices being "very good" (1), "good" (2), "moderate" (3), "bad" (4) or "very bad" (5). This scale is a robust predictor of mortality and correlates strongly with other objective health indicators. Lower values represent a better outcome.
Time Frame
Change in self-reported health/function from baseline to 8 weeks
Title
Change in self-reported physical function at 4 weeks
Description
This will be assessed with the Duke Activity Status Index (DASI). The DASI contains 12 items that inquire about activities of daily living (e.g., bathing), basic physical activity (e.g., walking, climbing stairs), and more strenuous physical function (e.g., vigorous sports) to gauge overall functional capacity. Higher values represent a better outcome (range 0-58.2).
Time Frame
Change in self-reported physical function from baseline to 4 weeks
Title
Change in self-reported physical function at 8 weeks
Description
This will be assessed with the Duke Activity Status Index (DASI). The DASI contains 12 items that inquire about activities of daily living (e.g., bathing), basic physical activity (e.g., walking, climbing stairs), and more strenuous physical function (e.g., vigorous sports) to gauge overall functional capacity. Higher values represent a better outcome (range 0-58.2).
Time Frame
Change in self-reported physical function from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Facility Information:
Facility Name
Jeff Huffman
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Piloting Text Messages to Promote Positive Affect and Physical Activity

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