Acute Coronary SyndromeNCT04077229
Piloting Text Messages to Promote Positive Affect and Physical Activity
A study testing Intervention arm: Text Message Intervention in people with Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Intervention arm: Text Message Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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
- Being tested
- Intervention arm: Text Message Intervention
- Keywords
- ACS, Text Message, Positive Psychology, Health Behavior
- Medical subject headings
- Acute Coronary Syndrome, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention arm: Text Message InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Intervention arm: Text Message Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of text messages successfully delivered to participants
Feasibility will be measured by calculating the percentage of text messages successfully delivered to participants.
Measured: 4 weeks
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).
Measured: 4 weeks
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).
Measured: 4 weeks
Secondary outcomes (18)
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.
Measured: Change in positive affect from baseline to 4 weeks
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.
Measured: Change in positive affect from baseline to 8 weeks
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.
Measured: Change in optimism from baseline to 4 weeks
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.
Measured: Change in optimism from baseline to 8 weeks
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.
Measured: Change in determination from baseline to 4 weeks
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.
Measured: Change in determination from baseline to 8 weeks
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.
Measured: Change in depression from baseline to 4 weeks
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.
Measured: Change in depression from baseline to 8 weeks
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.
Measured: Change in anxiety from baseline to 4 weeks
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.
Measured: Change in anxiety from baseline to 8 weeks
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.
Measured: Change in self-reported physical activity from baseline to 4 weeks
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.
Measured: Change in self-reported physical activity from baseline to 8 weeks
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.
Measured: Change in dietary adherence from baseline to 4 weeks
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.
Measured: Change in dietary adherence from baseline to 8 weeks
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.
Measured: Change in self-reported health/function from baseline to 4 weeks
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.
Measured: Change in self-reported health/function from baseline to 8 weeks
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).
Measured: Change in self-reported physical function from baseline to 4 weeks
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).
Measured: Change in self-reported physical function from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study startSep 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff C. Huffman, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077229
- Sponsor's protocol ID
- 2016P001472
- Status last verified
- Feb 2020
- First submitted
- 28 Aug 2019
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Text Messages to Promote Positive Affect and Physical Activity
- ClinicalTrials.gov ID
- NCT04077229
- Acronym / sponsor ID
- 2016P001472
- Conditions
- Acute Coronary Syndrome
- Keywords
- ACS, Text Message, Positive Psychology, Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention arm: Text Message InterventionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Prior acute coronary syndrome.
- Ability to receive text messages via cellular phone.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention arm: Text Message InterventionParticipants 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. | Behavioural | Intervention |
Primary outcome
Percentage of text messages successfully delivered to participants
Time frame: 4 weeks
Feasibility will be measured by calculating the percentage of text messages successfully delivered to participants.
Participant burden
Time frame: 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
Time frame: 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).
18 secondary outcomes
Change in Positive Affect at 4 weeks
Time frame: Change in positive affect from baseline to 4 weeks
Change in Positive Affect at 8 weeks
Time frame: Change in positive affect from baseline to 8 weeks
Change in Optimism at 4 weeks
Time frame: Change in optimism from baseline to 4 weeks
Change in Optimism at 8 weeks
Time frame: Change in optimism from baseline to 8 weeks
Change in Determination at 4 weeks
Time frame: Change in determination from baseline to 4 weeks
Change in Determination at 8 weeks
Time frame: Change in determination from baseline to 8 weeks
Change in Depression at 4 weeks
Time frame: Change in depression from baseline to 4 weeks
Change in Depression at 8 weeks
Time frame: Change in depression from baseline to 8 weeks
Change in Anxiety at 4 weeks
Time frame: Change in anxiety from baseline to 4 weeks
Change in Anxiety at 8 weeks
Time frame: Change in anxiety from baseline to 8 weeks
Change in Self-reported physical activity at 4 weeks
Time frame: Change in self-reported physical activity from baseline to 4 weeks
Change in Self-reported physical activity at 8 weeks
Time frame: Change in self-reported physical activity from baseline to 8 weeks
Change in Self-reported dietary adherence at 4 weeks
Time frame: Change in dietary adherence from baseline to 4 weeks
Change in Self-reported dietary adherence at 8 weeks
Time frame: Change in dietary adherence from baseline to 8 weeks
Change in Self-reported health/function at 4 weeks
Time frame: Change in self-reported health/function from baseline to 4 weeks
Change in Self-reported health/function at 8 weeks
Time frame: Change in self-reported health/function from baseline to 8 weeks
Change in self-reported physical function at 4 weeks
Time frame: Change in self-reported physical function from baseline to 4 weeks
Change in self-reported physical function at 8 weeks
Time frame: Change in self-reported physical function from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm: Text Message Intervention in people with Acute Coronary Syndrome, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of text messages successfully delivered to participants (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.