NCT03346278

Brief Summary

Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low. This study will examine if a mobile phone intervention that uses a text messaging program can successfully promote participation in cardiac rehabilitation.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 7, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 8, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

November 8, 2017

Last Update Submit

July 10, 2018

Conditions

Myocardial InfarctionPercutaneous Coronary InterventionCoronary Artery Bypass SurgeryHeart Valve Repair or ReplacementHeart TransplantLeft Ventricular Assist DeviceChronic Stable AnginaChronic Stable Heart Failure

Keywords

Cardiac RehabilitationText Messaging

Outcome Measures

Primary Outcomes (1)

  • Attendance at cardiac rehab

    Documented attendance at one or more cardiac rehab sessions. Primary analysis will compare the proportion attending cardiac rehab in the text message intervention and no text message intervention arms.

    6 months

Secondary Outcomes (17)

  • Number of cardiac rehab sessions attended

    6 months

  • Physical activity

    6 months

  • Exercise capacity

    6 months

  • Tobacco use

    6 months

  • Diet

    6 months

  • +12 more secondary outcomes

Study Arms (2)

No Text Message Intervention

NO INTERVENTION

Participants will receive usual care of information on CR and clinical referral to CR.

Text Message Intervention

EXPERIMENTAL

Participants randomized to the intervention will receive usual care plus a text messaging intervention.

Behavioral: Text Messaging Intervention

Interventions

Text Messaging InterventionBEHAVIORAL

After completing baseline procedures, study staff will activate the intervention in the participant's profile on the text messaging platform if the participant was randomized to the intervention. The text messaging platform will deliver messages by an automated algorithm. Participants will receive 4 messages per week for 6 months.

Text Message Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Part 1: Diagnosis eligible for cardiac rehabilitation within 90 days (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device, chronic stable angina, chronic stable heart failure)
  • Part 2: Hospitalized for diagnosis eligible for cardiac rehabilitation (myocardial infarction, percutaneous coronary intervention, coronary artery bypass surgery, heart valve repair/replacement, heart transplant, left ventricular assist device)
  • Eligible for cardiac rehabilitation
  • Owns a smartphone capable of receiving and sending SMS text messages

You may not qualify if:

  • Unable to communicate in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionAngina, Stable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Alexis Beatty, MD, MAS

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Medicine

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 17, 2017

Study Start

November 7, 2017

Primary Completion

May 3, 2018

Study Completion

May 3, 2018

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations

US(1)