- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00602485
The Effect of Action Control Based Intervention on Adherence After Cardiac Rehabilitaiton
The Effect of Action Control Based Interventions on Adherence to Prescribed Exercise and Diet Regimens for Patients Completing a Cardiac Rehabilitation Program Intervetnion on
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:
- 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
- examine whether there is a difference in response to the ACBI between state-oriented individuals and action-oriented individuals.
- test the interaction effect between action-orientation disposition and the intervention.
Study Overview
Detailed Description
Patients with cardiac problems are burdened with complex lifestyle changes involving medication, diet and exercise. Non-adherence to prescribed treatment protocols is a major contributor to morbidity and mortality for these indiviudals. Rehabbilitation programs provide the necessary education and supervision needed to promote health, however, non-adherence occurs even for those indiviudals with appropriate resources and motivation. Most of the research up to this point deals with preparing indiviudals to be adherent. Action Control theory is focused on the mental processes that occur between the time an individual makes a decision to adhere and the moment when the appropriate activty either occurs or does not occur.
This interventions tudy will compare rates of adherece between indivudals who receive an action control based educational intervention and those who do not.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Ohio
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Akron, Ohio, United States, 44309
- Summa Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-English literate, uner teh age of 21
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
self-report adherence to exercise and diet prescriptions
Time Frame: 6 weeks post cardaic rehabilitation
|
6 weeks post cardaic rehabilitation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
action control orientaiton based on adherence
Time Frame: 6 weeks post cardaic rehabilitaiotn
|
6 weeks post cardaic rehabilitaiotn
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carrie J Scotto, PhD, Summa Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R07026
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