Behavior Change InterventionsP-PLAC 2NCT04113213
Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health
A study testing Lifestyle Prescription (LRx) in people with Behavior Change Interventions and Cardiovascular Diseases, run by University of South Wales at 1 site in United Kingdom.
Trial summary
Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Behavior Change Interventions, Cardiovascular Diseases, Cardiovascular Risk Factor
- What is being tested?
- Lifestyle Prescription (LRx)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2019to 31 Jan 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 and over.
- Able and willing to provide written informed consent.
- Understands spoken and written English.
Who cannot join
- Participant is unwilling or unable to provide written informed consent.
- Participant is pregnant.
- Participant has a diagnosed psychological disorder.
- Participant has a drug dependency.
- Participant is housebound, or resides in a nursing home.
- Participant has behavioural issues or learning difficulties.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of South Wales
Pontypridd, Wales, CF37 1DL
About this study
Official title: Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.
P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.
If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).
- Conditions
- Behavior Change Interventions, Cardiovascular Diseases, Cardiovascular Risk Factor, Behavior, Health
- Being tested
- Lifestyle Prescription (LRx)
- Medical subject headings
- Cardiovascular Diseases, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Prescription (LRx)Behavioural
Lifestyle prescription, based on the UK WP10 medicinal prescription form. Includes advice and guidance regarding physical activity, diet, smoking and alcohol consumption.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard care during consultations. |
| Intervention | Experimental | Standard care during consultations with the addition of a physical lifestyle prescription. Receives: Behavioral: Lifestyle Prescription (LRx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
A prescription (LRx) being issued during a consultation
Number of a co- signed prescription (LRx) forms. Total number of forms to be co-signed = 120.
Measured: During month 7 of the study
Patient view of the prescription (LRx) and consultation Questionnaire
Completed study questionnaires. Total number of questionnaires to be completed = 120. Responses will be recorded to gain feedback from the patient participants regarding their thoughts and feelings of their consultation with and without the intervention of the prescription (LRx) - control vs interventional group. Initials responses from the questionnaires will be compared with the participants 3mth post consultation questionnaire to establish if they acted upon the guidance offered, and if they're thought and feelings had changed during the time.
Scale: 7 (minimum) to 41 (maximum). A lower value represents a better (more positive) outcome.
Measured: During month 7 of the study
Healthcare Practitioner (HCP) view of the prescription (LRx) and consultation Questionnaire
Completed clinician questionnaires. Total number of questionnaires to be completed = 12. Responses will be recorded to gain feedback from the clinicians regarding their thoughts and feelings of their consultations with and without the intervention of the prescription (LRx).
Sections 1 to 3:
Section 1 Scale: 9 to 54 (a lower score represents a better, more positive outcome) Section 2 Scale: 8 to 48 (a lower score represents a better, more positive outcome) Section 3 Scale: 6 to 36 (a lower score represents a better, more positive outcome)
Total score available: 23 to 138
Measured: during month 7 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start5 Oct 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Why it stopped: CV-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior Change InterventionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The study is an interventional controlled observational study based in the Primary Care setting. Control groups will be utilized through the mechanism of wait-listing the enrolment of recruitment centres into the study. Mixed methods will be used for both data collection and analysis. Historical clinical participant data (pre-intervention - from 12months) will be collected by the PI. Data will be collected immediately after the consultation and at 3 months post-intervention.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Wales, Cwm Taf University Health Board (NHS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113213
- Sponsor's protocol ID
- 260480
- Acronym
- P-PLAC 2
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health (Phase II)
- ClinicalTrials.gov ID
- NCT04113213
- Acronym / sponsor ID
- P-PLAC 2 / 260480
- Conditions
- Behavior Change Interventions, Cardiovascular Diseases, Cardiovascular Risk Factor, Behavior, Health
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: CV-19 pandemic
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of South WalesUniversity, hospital or other
- Collaborators
- Public Health Wales, Cwm Taf University Health Board (NHS)
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 2 Oct 2019 (actual)
- 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.
Prescribing lifestyle changes to patients who are at risk of cardiovascular disease, may be an extremely cost effective mechanism of improving health for the individual themselves and the NHS. It is already proven that positive lifestyle changes such as improved diet, increased physical activity, quitting smoking and reducing alcohol consumption can lower the risk of cardiovascular disease, as well as reduce the risk of all-cause mortality.
P-PLAC2 (Primary Care - Prescribing Lifestyle Adjustments for Cardiovascular Health) is a Phase II interventional study to determine the efficacy of a Lifestyle Prescription (LRx), from the viewpoint of patients and healthcare practitioners. The study uses a mixed methods design, and full study training and support will be provided to staff involved in the recruitment of patients, through to the behaviour change consultation, and end of study.
If the study proves successful, a lifestyle prescription (LRx) could then be made available to support NHS staff throughout all disciplines (specifically those working with patients who are at risk of cardiovascular disease (CVD).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is an interventional controlled observational study based in the Primary Care setting. Control groups will be utilized through the mechanism of wait-listing the enrolment of recruitment centres into the study. Mixed methods will be used for both data collection and analysis. Historical clinical participant data (pre-intervention - from 12months) will be collected by the PI. Data will be collected immediately after the consultation and at 3 months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard care during consultations. |
| Intervention | Experimental | Behavioral: Lifestyle Prescription (LRx)Standard care during consultations with the addition of a physical lifestyle prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and over.
- Able and willing to provide written informed consent.
- Understands spoken and written English.
Key exclusion criteria (6 listed)
- Participant is unwilling or unable to provide written informed consent.
- Participant is pregnant.
- Participant has a diagnosed psychological disorder.
- Participant has a drug dependency.
- Participant is housebound, or resides in a nursing home.
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 |
|---|---|---|
| Lifestyle Prescription (LRx)Lifestyle prescription, based on the UK WP10 medicinal prescription form. Includes advice and guidance regarding physical activity, diet, smoking and alcohol consumption. | Behavioural | Intervention |
Primary outcome
A prescription (LRx) being issued during a consultation
Time frame: During month 7 of the study
Number of a co- signed prescription (LRx) forms. Total number of forms to be co-signed = 120.
Patient view of the prescription (LRx) and consultation Questionnaire
Time frame: During month 7 of the study
Completed study questionnaires. Total number of questionnaires to be completed = 120. Responses will be recorded to gain feedback from the patient participants regarding their thoughts and feelings of their consultation with and without the intervention of the prescription (LRx) - control vs interventional group. Initials responses from the questionnaires will be compared with the participants 3mth post consultation questionnaire to establish if they acted upon the guidance offered, and if they're thought and feelings had changed during the time. Scale: 7 (minimum) to 41 (maximum). A lower value represents a better (more positive) outcome.
Healthcare Practitioner (HCP) view of the prescription (LRx) and consultation Questionnaire
Time frame: during month 7 of the study
Completed clinician questionnaires. Total number of questionnaires to be completed = 12. Responses will be recorded to gain feedback from the clinicians regarding their thoughts and feelings of their consultations with and without the intervention of the prescription (LRx). Sections 1 to 3: Section 1 Scale: 9 to 54 (a lower score represents a better, more positive outcome) Section 2 Scale: 8 to 48 (a lower score represents a better, more positive outcome) Section 3 Scale: 6 to 36 (a lower score represents a better, more positive outcome) Total score available: 23 to 138
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Prescription (LRx) in people with Behavior Change Interventions and Cardiovascular Diseases, run by University of South Wales at 1 site in United Kingdom.
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 3 inclusion and 6 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: paused, as of the sponsor's last update on 30 Jun 2021. 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 Kingdom. 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?
Results are not available in the source record.
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?
A prescription (LRx) being issued during a consultation (time frame: During month 7 of the study). The study lists 3 primary outcomes in all. 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 30 Jun 2021.