NCT03571581

Brief Summary

This study investigated the feasibility and acceptability of a phone-delivered mindfulness intervention to improve medication adherence among outpatients with heart failure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 27, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 11, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 29, 2022

Completed
Last Updated

July 14, 2025

Status Verified

August 1, 2022

Enrollment Period

1.4 years

First QC Date

June 5, 2018

Results QC Date

November 9, 2021

Last Update Submit

July 10, 2025

Conditions

Medication Non-adherence

Keywords

Medication adherenceHeart failureMindfulness interventions

Outcome Measures

Primary Outcomes (2)

  • Retention Rate

    Percentage of participants retained in the study (n enrolled/n retained X 100)

    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).

    3 months

Secondary Outcomes (3)

  • Self-reported Medication Adherence

    baseline, 3 months, 6 months

  • Objectively-assessed Medication Adherence

    baseline, 3 months, 6 months

  • Functional Capacity

    baseline, 3 months, 6 months

Other Outcomes (15)

  • The Flanker Inhibitory Control and Attention Test

    baseline, 3 months, 6 months

  • The Dimensional Change Card Sort Test

    Baseline, 3 months, 6 months

  • Oral Symbol Digit Test

    baseline, 3 months, 6 months

  • +12 more other outcomes

Study Arms (1)

Mindfulness Training (MT)

EXPERIMENTAL

Eight, 30-minute phone delivered MT sessions once a week for 8 weeks

Behavioral: Mindfulness Training (MT)

Interventions

Mindfulness Training (MT)BEHAVIORAL

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.

Mindfulness Training (MT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (4)

  • 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.

    PMID: 34099424BACKGROUND

  • Salmoirago-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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 35067596RESULT

MeSH Terms

Conditions

Medication AdherenceHeart Failure

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorHeart DiseasesCardiovascular Diseases

Limitations and Caveats

This study did not accrue the planned number of participants (n=50) due the to Covid-19 pandemic leading to a smaller than planned sample size.

Results Point of Contact

Title
Elena Salmoirago-Blotcher
Organization
The Miriam Hospital
Elena_Salmoirago_Blotcher@brown.edu
401-793-8325

Study Officials

  • Elena Salmoirago-Blotcher, MD, PhD

    The Miriam Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 5, 2018

First Posted

June 27, 2018

Study Start

October 11, 2018

Primary Completion

March 13, 2020

Study Completion

August 31, 2020

Last Updated

July 14, 2025

Results First Posted

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Once the main findings from the final research data set have been accepted for publication.
Access Criteria
Researchers interested in obtaining the de-identified data and associated documentation (e.g. codebook) can make a request to the principal investigator by email.

Locations

US(1)