SuicideNCT05791643
Promoting Safety Plan and Coping Strategy Use Among Adults With Suicidal Thoughts
A study testing Personalized internal and external coping strategies, Personalized internal coping strategies and Personalized external coping strategies in people with Suicide, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Personalized internal and external coping strategies, Personalized internal coping strategies and Personalized external coping strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2023to 3 Sep 2024
- 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
- Experiencing suicidal thoughts as part of their inpatient admission
- Ownership of and access to a smartphone (while on the unit and following discharge)
- Ability to speak and write English fluently
Who cannot join
- Any factor that impairs the ability to effectively participate in the study (e.g., significant cognitive impairment, intellectual disability, presence of violent behavior, psychotic illness/symptoms determined by the treating clinician to impair ability to understand the study or provide informed consent)
- Failure to correctly answer all true/false questions in the consent form
Trial locations and contacts
2 sites in 1 country.
United States2 sites
McLean Hospital
Belmont, Massachusetts, 02478
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Micro-Randomized Trial of a Real-Time Intervention for Promoting Safety Plan and Coping Strategy Use for Suicidal Thoughts
The goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. The main questions the investigators aim to answer are:
- Is a real-time, smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable?
- Does the real-time intervention result in increased use of safety plans and other coping strategies, and reduce suicidal thoughts?
Read more
Participants will:
- Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital
- When they report elevated suicidal thoughts on a smartphone survey, be randomly assigned to receive or not receive automated, interactive reminders to use content from their personalized safety plan or general coping strategies
- Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders
- Give feedback on their experience with the real-time intervention
Read the detailed description
Effective, scalable interventions for the highest-risk time for suicide - after inpatient psychiatric hospitalization - are urgently needed. The safety planning intervention (Stanley \& Brown, 2012) involves developing a personalized list of prioritized coping strategies for suicidal crises, and has been shown to prevent suicidal behavior (e.g., Nuij et al., 2021). However, roughly 40% of patients with a safety plan never use it (Stanley et al., 2016). The safety plan also includes multiple components (e.g., different internal coping strategies, seeking social support), yet little is known about the internal and external contexts that may impact the accessibility and effectiveness of individual safety plan components. Improving both the ability to promote safety plan use when needed and the understanding of when specific coping strategies are most accessible and effective has the potential to optimize this already evidence-based intervention.
The aim of this study is to leverage the recent micro-randomized trial (MRT) design (Klasnja et al., 2015) to evaluate the proximal effects of automated, interactive, smartphone-based reminders to implement the safety plan and its coping strategies at different levels of suicidal urges and intent. Twenty-five (N = 25) adults hospitalized for suicidal thoughts or behaviors will undergo an intensive longitudinal monitoring protocol, which includes completing up to six brief smartphone surveys per day that assess momentary suicidal urges and intent on a 0 to 10 scale during hospitalization and the 28 days after discharge. After each post-discharge survey with reported high intensity suicidal urges or moderate intent, participants will be "micro-randomized" to receive either a series of automated interactive intervention messages or no intervention. Whether the message content is personalized (from the individual's safety plan) or general (top-rated from others' safety plans) and the specific coping strategy type(s) recommended will also be randomized. Brief proximal follow-up surveys will assess coping strategy use since the last survey prompting micro-randomization, perceived helpfulness of any coping strategies used, and momentary suicidal urges and intent. Qualitative and quantitative data on acceptability and feasibility will be collected from participants and used to inform future real-time intervention refinements. Preliminary efficacy data will be used to inform the development of future, larger-scale studies and the ultimate development of policies for novel just-in-time adaptive interventions that deliver the right time of support, at the right time, and in the right context, for individuals at risk for suicide.
- Conditions
- Suicide
- Being tested
- Personalized internal and external coping strategies, Personalized internal coping strategies, Personalized external coping strategies, General internal and external coping strategies, General internal coping strategies
- Keywords
- Suicide, Suicidal Thoughts, Micro-Randomized Trial, Ecological Momentary Assessment, Real-Time Intervention
- Medical subject headings
- Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized internal and external coping strategiesBehavioural
A series of interactive, automated messages will recommend use of the internal coping strategies and external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan.
Personalized internal coping strategiesBehavioural
A series of interactive, automated messages will recommend use of the internal coping strategies from the participant's personalized safety plan.
Personalized external coping strategiesBehavioural
A series of interactive, automated messages will recommend use of the external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan.
General internal and external coping strategiesBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) common internal and external coping strategies for suicidal thoughts.
General internal coping strategiesBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) common internal coping strategies for suicidal thoughts.
General external coping strategiesBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) external coping strategies (i.e., sources of social support/distraction) for suicidal thoughts.
General internal coping strategies, relaxationBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, relaxation-based) coping strategies for suicidal thoughts.
General internal coping strategies, distractionBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, distraction-based) coping strategies for suicidal thoughts.
General internal coping strategies, physical activityBehavioural
A series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, physical activity-based) coping strategies for suicidal thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Real-time intervention for promoting safety plan and coping strategy use | Experimental | Momentary surveys in which elevated (non-zero but < 8 out of 10) levels of suicidal intent or high (>= 8 out of 10) suicidal urges are reported will be randomized either to receive a real-time intervention that consists of automated, interactive reminders with suggested strategies for coping with suicidal thoughts or no intervention.
If randomized to receive an intervention, the intervention type will also be randomized (at equal probabilities) to suggest either coping strategies from the participant's personalized safety plan or general common coping strategies. Receives: Behavioral: Personalized internal and external coping strategies; Behavioral: Personalized internal coping strategies; Behavioral: Personalized external coping strategies; Behavioral: General internal and external coping strategies; Behavioral: General internal coping strategies; Behavioral: General external coping strategies; Behavioral: General internal coping strategies, relaxation; Behavioral: General internal coping strategies, distraction; Behavioral: General internal coping strategies, physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention engagement as assessed by the number of real-time interventions received and percentage of real-time interventions completed
Engagement with the real-time intervention will be assessed by analyzing the total number interventions participants receive and the percentage of those received that they complete.
Measured: 4 weeks after hospital discharge
Extent to which the real-time intervention may be successfully used or implemented as assessed by the Feasibility of Intervention Measure
The extent to which the real-time intervention may be successfully used will be assessed by scoring and analyzing self-reported responses to the Feasibility of Intervention Measure.
Measured: 4 weeks after hospital discharge
Participant approval of the real-time intervention as assessed by the Acceptability of Intervention Measure
Participants' approval of the real-time intervention will be assessed by scoring and analyzing self-reported responses to the Acceptability of Intervention Measure.
Measured: 4 weeks after hospital discharge
Secondary outcomes (2)
Self-reported safety plan and coping strategy use
Participants may be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses safety plan and/or coping strategy use since the initial survey prompting micro-randomization.
Measured: Within two hours of each micro-randomization
Self-reported momentary suicidal urges and intent
Participants may be prompted within two hours of each micro-randomization to complete a brief follow-up smartphone survey that assesses momentary suicidal urge and intent (on a 0 to 10 scale).
Measured: Within two hours of each micro-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start5 Jul 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- Model description
- During the four weeks after hospital discharge, each time a participant reports elevated (\> 0 but \< 8 out of 10) levels of suicidal intent or high (\>= 8 out of 10) suicidal urge on a momentary smartphone survey, they will be randomized to either receive a real-time intervention or no real-time intervention promoting safety plan or coping strategy use. If randomized to receive a real-time intervention, the intervention type will also be randomized to consist of either recommended coping strategies from their personalized safety plan or general coping strategies for suicidal thoughts. During the post-discharge phase, participants will have 24/7 access to their full safety plan within the study app. At reported high (\>= 8 out of 10) levels of suicidal intent, no micro-randomization will occur, and a longstanding risk management protocol that includes direct, phone-based outreach to participants for further risk assessment and intervention will be used.
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca G. Fortgang, Ph.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791643
- Sponsor's protocol ID
- 2015P000598
- Status last verified
- Oct 2025
- First submitted
- 7 Mar 2023
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264. doi:10.1016/j.cbpra.2011.01.001
Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
PubMed 35048835Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.
PubMed 26828397Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
PubMed 26651463
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Micro-Randomized Trial of a Real-Time Intervention for Promoting Safety Plan and Coping Strategy Use for Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT05791643
- Acronym / sponsor ID
- 2015P000598
- Conditions
- Suicide
- Keywords
- Suicide, Suicidal Thoughts, Micro-Randomized Trial, Ecological Momentary Assessment, Real-Time Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 30 Mar 2023 (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 goal of this study is to learn about a new, real-time, smartphone-based intervention aimed to decrease risk for suicide in adults who have been hospitalized for suicidal thoughts or behaviors. The main questions the investigators aim to answer are:
- Is a real-time, smartphone-based intervention that promotes the use of safety plans and other coping strategies for suicidal thoughts feasible and acceptable?
- Does the real-time intervention result in increased use of safety plans and other coping strategies, and reduce suicidal thoughts?
Participants will:
- Answer questions about current suicidal thoughts on their smartphone up to 6 times each day while they are in the hospital and during the 4 weeks after they leave the hospital
- When they report elevated suicidal thoughts on a smartphone survey, be randomly assigned to receive or not receive automated, interactive reminders to use content from their personalized safety plan or general coping strategies
- Answer brief follow-up questions on their smartphone within a couple hours of receiving or not receiving automated reminders
- Give feedback on their experience with the real-time intervention
Detailed description
Effective, scalable interventions for the highest-risk time for suicide - after inpatient psychiatric hospitalization - are urgently needed. The safety planning intervention (Stanley \& Brown, 2012) involves developing a personalized list of prioritized coping strategies for suicidal crises, and has been shown to prevent suicidal behavior (e.g., Nuij et al., 2021). However, roughly 40% of patients with a safety plan never use it (Stanley et al., 2016). The safety plan also includes multiple components (e.g., different internal coping strategies, seeking social support), yet little is known about the internal and external contexts that may impact the accessibility and effectiveness of individual safety plan components. Improving both the ability to promote safety plan use when needed and the understanding of when specific coping strategies are most accessible and effective has the potential to optimize this already evidence-based intervention.
The aim of this study is to leverage the recent micro-randomized trial (MRT) design (Klasnja et al., 2015) to evaluate the proximal effects of automated, interactive, smartphone-based reminders to implement the safety plan and its coping strategies at different levels of suicidal urges and intent. Twenty-five (N = 25) adults hospitalized for suicidal thoughts or behaviors will undergo an intensive longitudinal monitoring protocol, which includes completing up to six brief smartphone surveys per day that assess momentary suicidal urges and intent on a 0 to 10 scale during hospitalization and the 28 days after discharge. After each post-discharge survey with reported high intensity suicidal urges or moderate intent, participants will be "micro-randomized" to receive either a series of automated interactive intervention messages or no intervention. Whether the message content is personalized (from the individual's safety plan) or general (top-rated from others' safety plans) and the specific coping strategy type(s) recommended will also be randomized. Brief proximal follow-up surveys will assess coping strategy use since the last survey prompting micro-randomization, perceived helpfulness of any coping strategies used, and momentary suicidal urges and intent. Qualitative and quantitative data on acceptability and feasibility will be collected from participants and used to inform future real-time intervention refinements. Preliminary efficacy data will be used to inform the development of future, larger-scale studies and the ultimate development of policies for novel just-in-time adaptive interventions that deliver the right time of support, at the right time, and in the right context, for individuals at risk for suicide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- During the four weeks after hospital discharge, each time a participant reports elevated (\> 0 but \< 8 out of 10) levels of suicidal intent or high (\>= 8 out of 10) suicidal urge on a momentary smartphone survey, they will be randomized to either receive a real-time intervention or no real-time intervention promoting safety plan or coping strategy use. If randomized to receive a real-time intervention, the intervention type will also be randomized to consist of either recommended coping strategies from their personalized safety plan or general coping strategies for suicidal thoughts. During the post-discharge phase, participants will have 24/7 access to their full safety plan within the study app. At reported high (\>= 8 out of 10) levels of suicidal intent, no micro-randomization will occur, and a longstanding risk management protocol that includes direct, phone-based outreach to participants for further risk assessment and intervention will be used.
| Arm | Type | Receives |
|---|---|---|
| Real-time intervention for promoting safety plan and coping strategy use | Experimental | Behavioral: Personalized internal and external coping strategies, Behavioral: Personalized internal coping strategies, Behavioral: Personalized external coping strategies, Behavioral: General internal and external coping strategies, Behavioral: General internal coping strategies, Behavioral: General external coping strategies, Behavioral: General internal coping strategies, relaxation, Behavioral: General internal coping strategies, distraction, Behavioral: General internal coping strategies, physical activityMomentary surveys in which elevated (non-zero but < 8 out of 10) levels of suicidal intent or high (>= 8 out of 10) suicidal urges are reported will be randomized either to receive a real-time intervention that consists of automated, interactive reminders with suggested strategies for coping with suicidal thoughts or no intervention. If randomized to receive an intervention, the intervention type will also be randomized (at equal probabilities) to suggest either coping strategies from the participant's personalized safety plan or general common coping strategies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experiencing suicidal thoughts as part of their inpatient admission
- Ownership of and access to a smartphone (while on the unit and following discharge)
- Ability to speak and write English fluently
Key exclusion criteria (2 listed)
- Any factor that impairs the ability to effectively participate in the study (e.g., significant cognitive impairment, intellectual disability, presence of violent behavior, psychotic illness/symptoms determined by the treating clinician to impair ability to understand the study or provide informed consent)
- Failure to correctly answer all true/false questions in the consent form
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 |
|---|---|---|
| Personalized internal and external coping strategiesA series of interactive, automated messages will recommend use of the internal coping strategies and external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| Personalized internal coping strategiesA series of interactive, automated messages will recommend use of the internal coping strategies from the participant's personalized safety plan. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| Personalized external coping strategiesA series of interactive, automated messages will recommend use of the external coping strategies (i.e., sources of social support/distraction) from the participant's personalized safety plan. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General internal and external coping strategiesA series of interactive, automated messages will recommend use of general (non-personalized) common internal and external coping strategies for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General internal coping strategiesA series of interactive, automated messages will recommend use of general (non-personalized) common internal coping strategies for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General external coping strategiesA series of interactive, automated messages will recommend use of general (non-personalized) external coping strategies (i.e., sources of social support/distraction) for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General internal coping strategies, relaxationA series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, relaxation-based) coping strategies for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General internal coping strategies, distractionA series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, distraction-based) coping strategies for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
| General internal coping strategies, physical activityA series of interactive, automated messages will recommend use of general (non-personalized) common internal (and specifically, physical activity-based) coping strategies for suicidal thoughts. | Behavioural | Real-time intervention for promoting safety plan and coping strategy use |
Primary outcome
Intervention engagement as assessed by the number of real-time interventions received and percentage of real-time interventions completed
Time frame: 4 weeks after hospital discharge
Engagement with the real-time intervention will be assessed by analyzing the total number interventions participants receive and the percentage of those received that they complete.
Extent to which the real-time intervention may be successfully used or implemented as assessed by the Feasibility of Intervention Measure
Time frame: 4 weeks after hospital discharge
The extent to which the real-time intervention may be successfully used will be assessed by scoring and analyzing self-reported responses to the Feasibility of Intervention Measure.
Participant approval of the real-time intervention as assessed by the Acceptability of Intervention Measure
Time frame: 4 weeks after hospital discharge
Participants' approval of the real-time intervention will be assessed by scoring and analyzing self-reported responses to the Acceptability of Intervention Measure.
2 secondary outcomes
Self-reported safety plan and coping strategy use
Time frame: Within two hours of each micro-randomization
Self-reported momentary suicidal urges and intent
Time frame: Within two hours of each micro-randomization
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 23 Oct 2025.
- BackgroundStanley B, Brown GK. Safety planning intervention: A brief intervention to mitigate suicide risk. Cognitive and Behavioral Practice. 2012; 19(2): 256-264. doi:10.1016/j.cbpra.2011.01.001
- Background: PubMed 35048835Nuij C, van Ballegooijen W, de Beurs D, Juniar D, Erlangsen A, Portzky G, O'Connor RC, Smit JH, Kerkhof A, Riper H. Safety planning-type interventions for suicide prevention: meta-analysis. Br J Psychiatry. 2021 Aug;219(2):419-426. doi: 10.1192/bjp.2021.50.
- Background: PubMed 26828397Stanley B, Chaudhury SR, Chesin M, Pontoski K, Bush AM, Knox KL, Brown GK. An Emergency Department Intervention and Follow-Up to Reduce Suicide Risk in the VA: Acceptability and Effectiveness. Psychiatr Serv. 2016 Jun 1;67(6):680-3. doi: 10.1176/appi.ps.201500082. Epub 2016 Feb 1.
- Background: PubMed 26651463Klasnja P, Hekler EB, Shiffman S, Boruvka A, Almirall D, Tewari A, Murphy SA. Microrandomized trials: An experimental design for developing just-in-time adaptive interventions. Health Psychol. 2015 Dec;34S(0):1220-8. doi: 10.1037/hea0000305.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized internal and external coping strategies, Personalized internal coping strategies and Personalized external coping strategies in people with Suicide, run by Massachusetts General Hospital at 2 sites 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 3 inclusion and 2 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 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Intervention engagement as assessed by the number of real-time interventions received and percentage of real-time interventions completed (time frame: 4 weeks after hospital discharge). 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?
On the ClinicalTrials.gov record for NCT05791643, which also lists 4 linked publications.
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 23 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.