NCT02670421

Brief Summary

Will the intervention (Heart SMART program) be feasible in moderate or high stress patients, who are referred to the Women's Heart and Preventive Cardiology clinics at Mayo Clinic?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

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

January 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

January 28, 2016

Last Update Submit

March 22, 2017

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

  • Change in Heart SMART Program survey score

    Baseline and 12 weeks

Secondary Outcomes (1)

  • Participant's adherence survey score to Heart SMART program

    16, 20 and 24 weeks

Study Arms (2)

Face to face Heart SMART program

ACTIVE COMPARATOR

Stress management program presented in a face to face meeting of 90-100 minutes with daily printed program instructions to follow over the next 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.

Behavioral: Face to Face Heart SMART ProgramBehavioral: Mayo Clinic Guide to Stress Free Living

Online Heart SMART program

ACTIVE COMPARATOR

Stress management program in the form of 10- minute videos completed weekly by participant on-line for 12 weeks, accompanied by reading from a book entitled The Mayo Clinic Guide to Stress Free Living.

Behavioral: On-line Heart SMART ProgramBehavioral: Mayo Clinic Guide to Stress Free Living

Interventions

Face to Face Heart SMART ProgramBEHAVIORAL

The Heart SMART stress management program survey consists of Perceived Stress Scale (PSS), Brief Resilience Scale (BRS), Patient Health Questionnaire (PHQ - 9) and Generalized Anxiety Disorder (GAD - 7), followed by email communication every three weeks.

Face to face Heart SMART program
On-line Heart SMART ProgramBEHAVIORAL

The Heart SMART stress management program survey consists of PSS (Perceived Stress Scale), BRS (Brief Resilience Scale), PHQ-9 (Patient Health Questionnaire) and GAD-7 (Generalized Anxiety Disorder) taken on-line in twelve, 10 minutes sessions.

Online Heart SMART program
Mayo Clinic Guide to Stress Free LivingBEHAVIORAL

All subjects will be provided with a copy of the book entitled Mayo Clinic Guide to Stress Free Living and encouraged to read it over the twelve week study period.

Face to face Heart SMART programOnline Heart SMART program

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 25-75 years.
  • Able to speak English and complete questionnaire.
  • Self-reported Stress Scale 6 - 10 (visual analog scale of 1 to 10 with 1 being lowest stress and 10 being highest stress)
  • Women in face to face session will have to be able to attend the SMART session.
  • Women in the online group will be required to have the ability to use internet to access the online training material.

You may not qualify if:

  • Self-reported Stress Index \<6
  • Pregnant women will be excluded from participation in the study. Pregnancy test is not required because the intervention in this study poses no risk
  • Unable to give written consent
  • Inability or refusal to cooperate with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Study Officials

  • Anjali Bhagra, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2016

First Posted

February 1, 2016

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

March 24, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)