Heart FailurePhase 1NCT00602485
The Effect of Action Control Based Intervention on Adherence After Cardiac Rehabilitaiton
A Phase 1 study of Heart Failure, run by Summa Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English literate, uner teh age of 21
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Action Control Education
- Keywords
- adherence, cardiac rehabilitation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action Control EducationOther
30 minute educational intervnetion
What is being measured
The primary outcome is the main question the study is designed to answer.
self-report adherence to exercise and diet prescriptions
Measured: 6 weeks post cardaic rehabilitation
Secondary outcomes (1)
action control orientaiton based on adherence
Measured: 6 weeks post cardaic rehabilitaiotn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summa Health System
- Sponsor type
- University, hospital or other
- Investigators
- Carrie J Scotto, PhD, Principal investigator, Summa Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602485
- Sponsor's protocol ID
- R07026
- Status last verified
- Sep 2009
- First submitted
- 15 Jan 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Action Control Based Interventions on Adherence to Prescribed Exercise and Diet Regimens for Patients Completing a Cardiac Rehabilitation Program Intervetnion on
- ClinicalTrials.gov ID
- NCT00602485
- Acronym / sponsor ID
- R07026
- Conditions
- Heart Failure
- Keywords
- adherence, cardiac rehabilitation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Summa Health SystemUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Non-English literate, uner teh age of 21
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action Control Education30 minute educational intervnetion | Other | – |
Primary outcome
self-report adherence to exercise and diet prescriptions
Time frame: 6 weeks post cardaic rehabilitation
1 secondary outcome
action control orientaiton based on adherence
Time frame: 6 weeks post cardaic rehabilitaiotn
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carrie J Scotto, PhD principal investigator
Summa Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Heart Failure, run by Summa Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
self-report adherence to exercise and diet prescriptions (time frame: 6 weeks post cardaic rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2009.