Medication Non-adherenceNCT03571581
Mind Your Heart Study
A study testing Mindfulness Training (MT) in people with Medication Non-adherence, run by The Miriam Hospital at 1 site in United States.
Trial summary
This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Non-adherence
- What is being tested?
- Mindfulness Training (MT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age > = 18
- Fluency in English language
- A confirmed diagnosis of heart failure
- Sub-optimal adherence to medications
- Access to a telephone
- Ability to understand and speak English
Who cannot join
- Unwillingness/inability to provide informed consent
- New York Heart Association (NYHA) class IV heart failure or clinically unstable
- Severe hearing impairment not allowing phone delivery
- Severe depressive symptoms
- Acute psychosis
- Severe cognitive impairment
- Recent hospitalization (< 6 weeks)
- Current (at least once a month) mind/body practice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.
This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.
Read the detailed description
This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with < 20% drop out rates by the end of the study and that > 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.
- Conditions
- Medication Non-adherence
- Being tested
- Mindfulness Training (MT)
- Keywords
- Medication adherence, Heart failure, Mindfulness interventions
- Medical subject headings
- Medication Adherence, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Training (MT)Behavioural
Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training (MT) | Experimental | Eight, 30-minute phone delivered MT sessions once a week for 8 weeks Receives: Behavioral: Mindfulness Training (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate
Percentage of participants retained in the study (n enrolled/n retained X 100)
Measured: 3 months, 6 months
Intervention Acceptability
Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5).
Measured: 3 months
Secondary outcomes (3)
Self-reported Medication Adherence
The Voils extent of non-adherence scale ranges from 1-5. Higher scores represent greater non-adherence.
Measured: baseline, 3 months, 6 months
Objectively-assessed Medication Adherence
Medication Event Monitoring Systems (MEMS). Proportion of medication taken/medication prescribed x 100, averaged over 30 days. Range is 0-100%. Lower values indicate worse adherence.
Measured: baseline, 3 months, 6 months
Functional Capacity
6-min walk test (6MWT) distance. The 6 min walk test measures the distance a patient can walk on a level course in 6 min. It is a measure of functional capacity that correlates with peak oxygen uptake and is positively associated with survival in patients with cardiovascular disease. A higher value (in meters) indicates better functional capacity. The 6MWT distance in healthy adults has been reported to range from 400 to 700 meters.
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2018
- Study start11 Oct 2018
- Primary completion13 Mar 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Medication Non-adherenceStudies of the same condition, open and under way.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Elena Salmoirago-Blotcher, The Miriam Hospital
- Investigators
- Elena Salmoirago-Blotcher, MD, PhD, Principal investigator, The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03571581
- Sponsor's protocol ID
- R21HL140492
- Other IDs
- R21HL140492
- Status last verified
- Aug 2022
- First submitted
- 5 Jun 2018
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. De-identified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be de-identified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
Publications
Salmoirago-Blotcher E. A treatment in search of a disease? Challenges in mindfulness research and practice. Explore (NY). 2022 Sep-Oct;18(5):509-514. doi: 10.1016/j.explore.2021.05.005. Epub 2021 May 26.
PubMed 34099424Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsinger S, Levine D, Breault C, Wu JR, Bock B, Cohen R. Exploring effects of mindfulness training on medication adherence in patients with heart failure: THE MIND YOUR HEART STUDY. Annals of Behavioral Medicine. 2021; 55: S210-S210.
Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Levine D, Breault C, Wu JR, and Cohen R.Effects Of Mindfulness Training On Cognitive Function And Interoceptive Awareness In Heart Failure Outpatients. Circulation 2021;144:A9159-A9159.
Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Breault C, Levine D, Wu JR, Cohen R. Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):595-602. doi: 10.1097/JCN.0000000000000891. Epub 2022 Jan 24.
PubMed 35067596
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Role of Mindfulness Training in the Promotion of Medication Adherence in Heart Failure Outpatients.
- ClinicalTrials.gov ID
- NCT03571581
- Acronym / sponsor ID
- R21HL140492
- Conditions
- Medication Non-adherence
- Keywords
- Medication adherence, Heart failure, Mindfulness interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Oct 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Posted 29 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.
Detailed description
This project seeked to study the role of mindfulness training (MT) in the promotion of medication adherence among patients with chronic heart failure (HF). A prospective pre/post design study was conducted among 50 stable outpatients with HF and sub-optimal self-reported medication adherence. MT sessions (one 30-min session/week over 8 weeks) were phone-delivered by qualified mindfulness instructors. Assessments were conducted at baseline, 3 months (end of the intervention) and 6 months since baseline. The primary outcomes were feasibility and acceptability. We hypothesized we would meet recruitment goals (n=50) within the study timeline, with < 20% drop out rates by the end of the study and that > 80% of participants would report high (=grade 5) enjoyment ratings on a self-report intervention enjoyment scale (range:1 to 5). Secondary outcomes were self-reported and objectively assessed medication adherence and functional capacity (a clinical marker of medication adherence. We hypothesized we would observe significant pre-post intervention improvements in medication adherence and functional capacity. Additional outcomes included possible mediators of intervention effect, i.e., cognitive function, mood, sleep quality, and interoceptive awareness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training (MT) | Experimental | Behavioral: Mindfulness Training (MT)Eight, 30-minute phone delivered MT sessions once a week for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > = 18
- Fluency in English language
- A confirmed diagnosis of heart failure
- Sub-optimal adherence to medications
- Access to a telephone
Key exclusion criteria (8 listed)
- Unwillingness/inability to provide informed consent
- New York Heart Association (NYHA) class IV heart failure or clinically unstable
- Severe hearing impairment not allowing phone delivery
- Severe depressive symptoms
- Acute psychosis
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 |
|---|---|---|
| Mindfulness Training (MT)Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 20 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor. | Behavioural | Mindfulness Training (MT) |
Primary outcome
Retention Rate
Time frame: 3 months, 6 months
Percentage of participants retained in the study (n enrolled/n retained X 100)
Intervention Acceptability
Time frame: 3 months
Self-reported intervention enjoyment scale (1 = did not enjoy to 5 = enjoyed very much). Scores range from 1 to 5; higher scores mean a better outcome. The metric for this study was the percentage of participants indicating high intervention enjoyment (a score of 5).
3 secondary outcomes
Self-reported Medication Adherence
Time frame: baseline, 3 months, 6 months
Objectively-assessed Medication Adherence
Time frame: baseline, 3 months, 6 months
Functional Capacity
Time frame: baseline, 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34099424Salmoirago-Blotcher E. A treatment in search of a disease? Challenges in mindfulness research and practice. Explore (NY). 2022 Sep-Oct;18(5):509-514. doi: 10.1016/j.explore.2021.05.005. Epub 2021 May 26.
- Results publicationSalmoirago-Blotcher E, Walaska K, Trivedi D, Dunsinger S, Levine D, Breault C, Wu JR, Bock B, Cohen R. Exploring effects of mindfulness training on medication adherence in patients with heart failure: THE MIND YOUR HEART STUDY. Annals of Behavioral Medicine. 2021; 55: S210-S210.
- Results publicationSalmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Levine D, Breault C, Wu JR, and Cohen R.Effects Of Mindfulness Training On Cognitive Function And Interoceptive Awareness In Heart Failure Outpatients. Circulation 2021;144:A9159-A9159.
- Results publication: PubMed 35067596Salmoirago-Blotcher E, Walaska K, Trivedi D, Dunsiger S, Breault C, Levine D, Wu JR, Cohen R. Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. J Cardiovasc Nurs. 2022 Nov-Dec 01;37(6):595-602. doi: 10.1097/JCN.0000000000000891. Epub 2022 Jan 24.
- Individual participant dataSharing planned: Yes. Data generated under the project will be shared as per the NIH Grant Policy and The Miriam Hospital IRB guidelines. De-identified research data will be made available in a timely manner once the main findings from the final research data set have been accepted for publication. Access to these data will be available for educational or research purposes. Data will be de-identified to avoid linkages to individual research participants and will not contain variables that could lead to the disclosure of the identity of individual subjects. All requestors will be asked to sign a data sharing agreement that includes conditions to 1) protect the identity of participants, 2) limit use of data for educational and research purposes, 3) prevent transfer of data to other users, and 4) acknowledge the data source. The de-identified data will be shared using Excel or SPSS file formats.
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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.
Elena Salmoirago-Blotcher, MD, PhD principal investigator
The Miriam 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 Mindfulness Training (MT) in people with Medication Non-adherence, run by The Miriam 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 6 inclusion and 8 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 14 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Retention Rate (time frame: 3 months, 6 months). The study lists 2 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 NCT03571581, 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 14 Jul 2025.