NCT00602485

Brief Summary

This will be a pilot study of the effect of an Action Control-based intervention (ACBI) on adherence to prescribed diet and exercise programs after cardaic rehabilitation. The purposes of this study are to:

  1. 1.determine if an ACBI has an effect on adherence to prescribed home exercise and diet regimens for individuals 6 weeks after participating in a cardiac rehabilitation program
  2. 2.examine whether there is a difference in response to the ACBI between state-oriented individuals and action-oriented individuals.
  3. 3.test the interaction effect between action-orientation disposition and the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for phase_1 heart-failure

Timeline
Completed

Started Jun 2007

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

September 18, 2009

Status Verified

September 1, 2009

Enrollment Period

1.7 years

First QC Date

January 15, 2008

Last Update Submit

September 17, 2009

Conditions

Heart Failure

Keywords

adherence, cardiac rehabilitation

Outcome Measures

Primary Outcomes (1)

  • self-report adherence to exercise and diet prescriptions

    6 weeks post cardaic rehabilitation

Secondary Outcomes (1)

  • action control orientaiton based on adherence

    6 weeks post cardaic rehabilitaiotn

Interventions

Action Control EducationOTHER

30 minute educational intervnetion

Eligibility Criteria

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

You may qualify if:

  • Participants will be a convenience sample of English literate men and women over the age of 21 enrolled in a cardiac rehabilitation program and accessible by phone for follow-up. All participants are referred to rehabilitation by their physician. Being enrolled in the program indicates the participants have experienced a serious cardiac event, either myocardial infarction and/or coronary surgery

You may not qualify if:

  • Non-English literate, uner teh age of 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System

Akron, Ohio, 44309, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carrie J Scotto, PhD

    Summa Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

June 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 18, 2009

Record last verified: 2009-09

Locations

US(1)