Physical ActivityNCT01673100
Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures
A study testing Physical Activity Promotion Intervention in people with Physical Activity, run by University of Nebraska at 2 sites in United States.
Trial summary
The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Physical Activity Promotion Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2011to 1 Sep 2014
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time PCI cardiac revascularization
- Age of 19 years or older
- Residing in a rural community
- Previously sedentary
- Physician approval to participate in this study
- Oriented to person, place, and time
- Able to see and hear (able to read the screen of a cell phone, and hear audio over a cell phone)
- Able to speak and read English.
Who cannot join
- Residing in area of Nebraska that does not have cell phone transmission
- Physical impairments limiting participation in physical activity and exercise following PCI
- Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bryan LGH Medical Center
Lincoln, Nebraska, 68516
Nebraska Heart Hospital
Lincoln, Nebraska, 68526
About this study
The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI).
Read the detailed description
Regular physical activity is important in the maintenance of cardiovascular health, and is especially critical for previously sedentary individuals who have undergone percutaneous coronary intervention (PCI) procedures. Changing behavior to adopt and maintain recommended physical activity levels in this population is difficult. Interventions to accomplish behavior change will not work unless they can be adopted into a person's busy lifestyle. This proposed study fills a gap by testing the feasibility of an innovative, targeted intervention (Physical Activity Promotion Telehealth Intervention), delivered by a practical and feasible platform (cell phone). The asynchronous targeted daily interaction will consist of 5-6 text, picture, and/or video messages delivered to the subject's cell phone each day. Upon successful completion of this study, it is believed that these feasibility findings will provide a foundation for the testing of a larger clinical trial to promote physical activity in this population.
- Conditions
- Physical Activity
- Being tested
- Physical Activity Promotion Intervention
- Keywords
- physical activity, percutaneous coronary intervention, heart disease
- Medical subject headings
- Motor Activity, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Activity Promotion InterventionBehavioural
Subjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. Depending on the subject's responses to the questionnaires at baseline (stages and processes of change) they will be given tips to help them engage in physical activity (such as messages to increase their self-efficacy or confidence, walking with a friend or spouse, breaking up physical activity bouts into 10 minutes bouts, etc.) and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity.
| Study group | Role | What they receive |
|---|---|---|
| Physical Activity Promotion Intervention | Experimental | Subjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. These messages will be tips to help them engage in physical activity and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity. Receives: Behavioral: Physical Activity Promotion Intervention |
| Atttention Control | No intervention | Subjects in the attention control group will receive only general health messages on their study cell phone (not physical activity promoting messages). They also will receive any usual post-PCI procedure care that all get. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility Aspects of the Physical Activity Telehealth Intervention
Evaluate the feasibility of each component of this pilot study, in order to refine the intervention for a larger clinical trial. This will include:
- Evaluate all aspects of implementation (numbers of subjects contacted, enrollment, attrition; problems and solutions identified using the telehealth platform, time for delivery; subject acceptance and perception).
- Evaluate feasibility of the data collection methods (time required for data collection, missing data, reliability estimates of outcomes).
- Estimate effect sizes for sample size determinations for a future, larger clinical trial.
Measured: 6 months
Secondary outcomes (1)
Physical Activity Measures
Pilot test the impact of the Physical Activity Promotion Telehealth Intervention in post-PCI patients over time compared to patients receiving attention only, on the following outcomes:
- Movement through the stages of readiness for physical activity.
- Behavior change constructs (self efficacy for exercise, decisional balance, and use of processes for change).
- Amount of physical activity (estimated energy expenditure per day as measured by the actigraph accelerometer) and exercise (reported minutes exercising per day).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study start1 Mar 2011
- Primary completion1 Sep 2014
- Study completion1 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Janet L Nieveen, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673100
- Sponsor's protocol ID
- 0178-09-FB
- Other IDs
- 5P20NR011404-03
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2012
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Telehealth Intervention After Percutaneous Coronary Procedures
- ClinicalTrials.gov ID
- NCT01673100
- Acronym / sponsor ID
- 0178-09-FB
- Conditions
- Physical Activity
- Keywords
- physical activity, percutaneous coronary intervention, heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Mar 2011 (actual)
- Primary completion
- 1 Sep 2014 (actual)
- Study completion
- 1 Sep 2014 (actual)
- First posted
- 27 Aug 2012 (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.
The purpose of this study is to test the feasibility of using targeted daily cell phone interaction to facilitate behavior change for physical activity in previously-sedentary individuals who have recently undergone a percutaneous coronary intervention (PCI).
Detailed description
Regular physical activity is important in the maintenance of cardiovascular health, and is especially critical for previously sedentary individuals who have undergone percutaneous coronary intervention (PCI) procedures. Changing behavior to adopt and maintain recommended physical activity levels in this population is difficult. Interventions to accomplish behavior change will not work unless they can be adopted into a person's busy lifestyle. This proposed study fills a gap by testing the feasibility of an innovative, targeted intervention (Physical Activity Promotion Telehealth Intervention), delivered by a practical and feasible platform (cell phone). The asynchronous targeted daily interaction will consist of 5-6 text, picture, and/or video messages delivered to the subject's cell phone each day. Upon successful completion of this study, it is believed that these feasibility findings will provide a foundation for the testing of a larger clinical trial to promote physical activity in this population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Activity Promotion Intervention | Experimental | Behavioral: Physical Activity Promotion InterventionSubjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. These messages will be tips to help them engage in physical activity and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity. |
| Atttention Control | No intervention | –Subjects in the attention control group will receive only general health messages on their study cell phone (not physical activity promoting messages). They also will receive any usual post-PCI procedure care that all get. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- First-time PCI cardiac revascularization
- Age of 19 years or older
- Residing in a rural community
- Previously sedentary
- Physician approval to participate in this study
Key exclusion criteria (3 listed)
- Residing in area of Nebraska that does not have cell phone transmission
- Physical impairments limiting participation in physical activity and exercise following PCI
- Evaluated by their physician to be TOO HIGH RISK for moderate physical activity as proposed in this study
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 |
|---|---|---|
| Physical Activity Promotion InterventionSubjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. Depending on the subject's responses to the questionnaires at baseline (stages and processes of change) they will be given tips to help them engage in physical activity (such as messages to increase their self-efficacy or confidence, walking with a friend or spouse, breaking up physical activity bouts into 10 minutes bouts, etc.) and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity. | Behavioural | Physical Activity Promotion Intervention |
Primary outcome
Feasibility Aspects of the Physical Activity Telehealth Intervention
Time frame: 6 months
Evaluate the feasibility of each component of this pilot study, in order to refine the intervention for a larger clinical trial. This will include: * Evaluate all aspects of implementation (numbers of subjects contacted, enrollment, attrition; problems and solutions identified using the telehealth platform, time for delivery; subject acceptance and perception). * Evaluate feasibility of the data collection methods (time required for data collection, missing data, reliability estimates of outcomes). * Estimate effect sizes for sample size determinations for a future, larger clinical trial.
1 secondary outcome
Physical Activity Measures
Time frame: 6 months
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 6 Sep 2023.
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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.
Janet L Nieveen, PhD, RN principal investigator
University of Nebraska
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity Promotion Intervention in people with Physical Activity, run by University of Nebraska at 2 sites 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 8 inclusion and 3 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Feasibility Aspects of the Physical Activity Telehealth Intervention (time frame: 6 months). 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 6 Sep 2023.