Chest PainNCCPNCT04904198
A Care Management Intervention for Non-cardiac Chest Pain
A study testing Care Management Intervention for non-cardiac chest pain in people with Chest Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chest Pain
- What is being tested?
- Care Management Intervention for non-cardiac chest pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to 8 Jan 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of non-cardiac chest pain, defined as chest pain recurring at least once per week for two weeks with at least two of the following objective tests: (1) electrocardiogram without ischemic changes; (2) negative cardiac enzymes; (3) non-ischemic cardiac stress test.
- Primary care physician affiliated with the institution
Who cannot join
- History or subsequent diagnosis of cardiac disease
- Objectively diagnosed alternative medical etiology of chest pain (e.g., gastroesophageal disease)
- Resolution of chest pain prior to enrollment
- Cognitive impairment, assessed using a six-item screen
- Inability to communicate in English
- Lack of telephone access (precluding weekly phone call participation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.
Read the detailed description
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. The care management team consisted of a nurse, cardiologist, and psychiatrist. Following a one-time consultation visit with the cardiologist and nurse, evaluation and treatment recommendations were conveyed to the participant's primary care physician. Then, the nurse completed eight weekly phone calls with the participant to provide support, introduce therapeutic principles, and assist with coordination of care, under the supervision of a psychiatrist. Intervention feasibility was assessed on several domains including adherence, recruitment, attrition, safety, and data collection. To examine preliminary efficacy, participants completed Likert scales of chest pain symptom severity, frequency and impact, and measures of psychological health (Patient Health Questionnaire-9, General Anxiety Disorder-7, Patient Health Questionnaire-15) and health-related quality of life (12-Item Short Form Survey) at baseline and intervention completion.
- Conditions
- Chest Pain
- Being tested
- Care Management Intervention for non-cardiac chest pain
- Keywords
- non-cardiac chest pain, atypical chest pain, collaborative care
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Management Intervention for non-cardiac chest painBehavioural
Multicomponent eight-week care management intervention involving a consultation visit with a cardiologist and nurse. Recommendations from the consultation visit are conveyed to the primary care physician. Following the visit, the participant has eight weekly phone calls with a nurse to provide support, introduce therapeutic principals, and assess symptoms. The study nurse is supervised by a psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Care Management Intervention for Non-cardiac chest pain | Experimental | Multicomponent care management intervention. Receives: Behavioral: Care Management Intervention for non-cardiac chest pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of adherence
A priori, feasible adherence was defined as 100% completion of the consultation visit and a mean completion of at least half of the eight phone calls over the eight-week study period.
Measured: Week 8
Secondary outcomes (12)
Feasibility of recruitment
Collect data on the proportion of individuals interested in the study who meet eligibility criteria for participation
Measured: Baseline
Feasibility of intervention attrition
A priori, an attrition rate of less than or equal to 15% was defined as indicating intervention feasibility
Measured: Week 8
Feasibility of intervention safety
Any adverse psychological or physical symptoms were documented throughout the study intervention with appropriate follow-up to ensure safety
Measured: Week 8
Feasibility of data collection at baseline
Assessment of whether participants would be able to complete all baseline study measures
Measured: Baseline
Feasibility of data collection at follow-up
Assessment of whether participants would be able to complete all follow-up study measures
Measured: Week 8
Change in chest pain symptom severity
Likert scale from 0 (no pain) to 10 (severe pain)
Measured: Change from baseline at week 8
Change in chest pain symptom frequency
Likert scale from 0 (infrequent) to 10 (very frequent)
Measured: Change from baseline at week 8
Change in chest pain symptom impact
Likert scale from 0 (no impact) to 10 (severe impact)
Measured: Change from baseline at week 8
Change in depressive symptoms
Patient Health Questionnaire-9, score range of 0-27, higher numbers reflect more severe symptoms.
Measured: Change from baseline at week 8
Change in anxiety symptoms
General Anxiety Disorder-7, score range of 0-21, higher numbers reflect more severe symptoms.
Measured: Change from baseline at week 8
Change in somatic symptom disorder/somatization symptoms
Patient Health Questionnaire-15, score range of 0-30, higher numbers reflect more severe symptoms.
Measured: Change from baseline at week 8
Change in health-related quality of life
12-Item Short Form Survey. Generates a physical health composite summary and a mental health composite summary. The mean score is set to 50 for each composite score. Scores > 50 indicate better physical or mental health-related quality of life than the mean, and scores < 50 indicate worse physical or mental health-related quality of life than the mean.
Measured: Change from baseline at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start22 Mar 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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
- 3 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
- Investigators
- Jeff C Huffman, M.D., Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904198
- Sponsor's protocol ID
- 2017P002331
- Acronym
- NCCP
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madva EN, Celano CM, Kim S, Bell M, Radfar A, Ibrahim NE, Dar T, Albanese A, Tawakol A, Huffman JC. A Care Management Intervention for Noncardiac Chest Pain: Treatment Development and Feasibility Assessment. Prim Care Companion CNS Disord. 2022 Apr 19;24(2):21m03045. doi: 10.4088/PCC.21m03045.
PubMed 35452569
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Care Management Intervention for Non-cardiac Chest Pain: Intervention Development and Feasibility Assessment
- ClinicalTrials.gov ID
- NCT04904198
- Acronym / sponsor ID
- NCCP / 2017P002331
- Conditions
- Chest Pain
- Keywords
- non-cardiac chest pain, atypical chest pain, collaborative care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 27 May 2021 (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 investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. Team members including a cardiologist, nurse, and psychiatrist. Impressions and recommendations were shared with the patient's primary care physician. Measures of chest pain severity, frequency and impact and measures of psychological health and health-related quality of life were completed at baseline and intervention completion.
Detailed description
The investigators developed and implemented an eight-week multicomponent care management intervention for non-cardiac chest pain. The care management team consisted of a nurse, cardiologist, and psychiatrist. Following a one-time consultation visit with the cardiologist and nurse, evaluation and treatment recommendations were conveyed to the participant's primary care physician. Then, the nurse completed eight weekly phone calls with the participant to provide support, introduce therapeutic principles, and assist with coordination of care, under the supervision of a psychiatrist. Intervention feasibility was assessed on several domains including adherence, recruitment, attrition, safety, and data collection. To examine preliminary efficacy, participants completed Likert scales of chest pain symptom severity, frequency and impact, and measures of psychological health (Patient Health Questionnaire-9, General Anxiety Disorder-7, Patient Health Questionnaire-15) and health-related quality of life (12-Item Short Form Survey) at baseline and intervention completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Management Intervention for Non-cardiac chest pain | Experimental | Behavioral: Care Management Intervention for non-cardiac chest painMulticomponent care management intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of non-cardiac chest pain, defined as chest pain recurring at least once per week for two weeks with at least two of the following objective tests: (1) electrocardiogram without ischemic changes; (2) negative cardiac enzymes; (3) non-ischemic cardiac stress test.
- Primary care physician affiliated with the institution
Key exclusion criteria (6 listed)
- History or subsequent diagnosis of cardiac disease
- Objectively diagnosed alternative medical etiology of chest pain (e.g., gastroesophageal disease)
- Resolution of chest pain prior to enrollment
- Cognitive impairment, assessed using a six-item screen
- Inability to communicate in English
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 |
|---|---|---|
| Care Management Intervention for non-cardiac chest painMulticomponent eight-week care management intervention involving a consultation visit with a cardiologist and nurse. Recommendations from the consultation visit are conveyed to the primary care physician. Following the visit, the participant has eight weekly phone calls with a nurse to provide support, introduce therapeutic principals, and assess symptoms. The study nurse is supervised by a psychiatrist. | Behavioural | Care Management Intervention for Non-cardiac chest pain |
Primary outcome
Feasibility of adherence
Time frame: Week 8
A priori, feasible adherence was defined as 100% completion of the consultation visit and a mean completion of at least half of the eight phone calls over the eight-week study period.
12 secondary outcomes
Feasibility of recruitment
Time frame: Baseline
Feasibility of intervention attrition
Time frame: Week 8
Feasibility of intervention safety
Time frame: Week 8
Feasibility of data collection at baseline
Time frame: Baseline
Feasibility of data collection at follow-up
Time frame: Week 8
Change in chest pain symptom severity
Time frame: Change from baseline at week 8
Change in chest pain symptom frequency
Time frame: Change from baseline at week 8
Change in chest pain symptom impact
Time frame: Change from baseline at week 8
Change in depressive symptoms
Time frame: Change from baseline at week 8
Change in anxiety symptoms
Time frame: Change from baseline at week 8
Change in somatic symptom disorder/somatization symptoms
Time frame: Change from baseline at week 8
Change in health-related quality of life
Time frame: Change from baseline at week 8
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 27 May 2021.
- Derived from this study: PubMed 35452569Madva EN, Celano CM, Kim S, Bell M, Radfar A, Ibrahim NE, Dar T, Albanese A, Tawakol A, Huffman JC. A Care Management Intervention for Noncardiac Chest Pain: Treatment Development and Feasibility Assessment. Prim Care Companion CNS Disord. 2022 Apr 19;24(2):21m03045. doi: 10.4088/PCC.21m03045.
- Individual participant dataSharing planned: No
Related trials for Chest Pain
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CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
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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.
Jeff C Huffman, M.D. principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Management Intervention for non-cardiac chest pain in people with Chest Pain, 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 2 inclusion and 6 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 27 May 2021. 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?
Feasibility of adherence (time frame: Week 8). 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 NCT04904198, which also lists 1 linked publication.
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 27 May 2021.