High CholesterolRISAPNCT01187056
The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice
A study testing Training programme in people with High Cholesterol and Cardiovascular Disease, run by University of Aarhus.
Trial summary
General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Cholesterol, Cardiovascular Disease
- What is being tested?
- Training programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jul 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GPs in Region Central and Region North, Denmark, are invited to the study.
- Patients are at least 18 years old, and have high cholesterol corresponding to a recommendation for cholesterol-reducing medication according to Danish clinical guideline for general practice. The patients are recruited after their high cholesterol has been detected and when treatment options are to be discussed.
Who cannot join
- Patients with CVD or DM are excluded from the study, as are patients already receiving cholesterol-reducing medication and patients unable to speak and read Danish.
About this study
General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication for disease prevention are needed, as are studies about risk communication training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations. Hypothesis: 1) patients have better adherence to chosen treatment.
The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.
Read more
The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction.
The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment, self-rated health, patient enablement, and risk communication and decision-making effectiveness. Prescriptions, contacts to the health services, and cholesterol level will be drawn from the register of the National Health Service of Denmark at baseline and at 6 months.
In both intervention group and active control group, 12 consultations will be observed and tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme. The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to describe and analyse research choices, adaptation of intervention model to the specific context, and GPs' and patients' reactions to trial participation.
- Conditions
- High Cholesterol, Cardiovascular Disease
- Being tested
- Training programme
- Keywords
- Shared decision-making, Risk information, Decision aids
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programmeBehavioural
Also called decision making, decision aids
2 x 2 hours of training (workshops)
| Study group | Role | What they receive |
|---|---|---|
| Training, decision making | Experimental | General practitioners receive training in shared decision-making and risk communication, and use their newly acquired skills in real-life consultations with 7 patients with high cholesterol. Receives: Behavioral: Training programme |
| Training, usual practice | Active comparator | The control group GPs will receive 2 hours of training in the primary care guideline for prevention of cardiovascular disease Receives: Behavioral: Training programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary patient outcome is adherence to treatment choice.
Measured: 2010-08-01 - 2011-04-01
Secondary outcomes (7)
satisfaction with decision.
Measured: 2010-08-01 - 2011-04-01
self-rated health
Measured: 2010-08-01 - 2011-04-01
anxiety
Measured: 2010-08-01 - 2011-04-01
enablement
Measured: 2010-08-01 - 2011-04-01
satisfaction with communication,
Measured: 2010-08-01 - 2011-04-01
satisfaction and confidence in decision
Measured: 2010-08-01 - 2011-04-01
number of contacts to health services
Measured: 2010-08-01 - 2011-04-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startNov 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for High CholesterolStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Janus L Thomsen, MD, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187056
- Sponsor's protocol ID
- 2007-41-1446
- Acronym
- RISAP
- Status last verified
- Oct 2012
- First submitted
- 20 Aug 2010
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirkegaard P, Edwards A, Risor MB, Thomsen JL. Risk of cardiovascular disease? A qualitative study of risk interpretation among patients with high cholesterol. BMC Fam Pract. 2013 Sep 16;14:137. doi: 10.1186/1471-2296-14-137.
PubMed 24040920Kirkegaard P, Risor MB, Edwards A, Junge AG, Thomsen JL. Speaking of risk, managing uncertainty: decision-making about cholesterol-reducing treatment in general practice. Qual Prim Care. 2012;20(4):245-52.
PubMed 23113909Kirkegaard P, Edwards AG, Hansen B, Hansen MD, Jensen MS, Lauritzen T, Risoer MB, Thomsen JL. The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice. BMC Fam Pract. 2010 Sep 22;11:70. doi: 10.1186/1471-2296-11-70.
PubMed 20860820
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RISAP-study: a Complex Intervention in Risk Communication and Shared Decision-making in General Practice
- ClinicalTrials.gov ID
- NCT01187056
- Acronym / sponsor ID
- RISAP / 2007-41-1446
- Conditions
- High Cholesterol, Cardiovascular Disease
- Keywords
- Shared decision-making, Risk information, Decision aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Aug 2010 (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.
General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication for disease prevention are needed, as are studies about risk communication training for GPs. Aim: 1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations. Hypothesis: 1) patients have better adherence to chosen treatment.
The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.
The GPs receive a questionnaire at baseline and after 6 months about their attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction.
The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment, self-rated health, patient enablement, and risk communication and decision-making effectiveness. Prescriptions, contacts to the health services, and cholesterol level will be drawn from the register of the National Health Service of Denmark at baseline and at 6 months.
In both intervention group and active control group, 12 consultations will be observed and tape-recorded. The consultations will be divided between 4 GPs with each 3 patients. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme. The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to describe and analyse research choices, adaptation of intervention model to the specific context, and GPs' and patients' reactions to trial participation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training, decision making | Experimental | Behavioral: Training programmeGeneral practitioners receive training in shared decision-making and risk communication, and use their newly acquired skills in real-life consultations with 7 patients with high cholesterol. |
| Training, usual practice | Active comparator | Behavioral: Training programmeThe control group GPs will receive 2 hours of training in the primary care guideline for prevention of cardiovascular disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GPs in Region Central and Region North, Denmark, are invited to the study.
- Patients are at least 18 years old, and have high cholesterol corresponding to a recommendation for cholesterol-reducing medication according to Danish clinical guideline for general practice. The patients are recruited after their high cholesterol has been detected and when treatment options are to be discussed.
Key exclusion criteria (1 listed)
- Patients with CVD or DM are excluded from the study, as are patients already receiving cholesterol-reducing medication and patients unable to speak and read Danish.
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 |
|---|---|---|
| Training programmeAlso: decision making, decision aids2 x 2 hours of training (workshops) | Behavioural | Training, decision making, Training, usual practice |
Primary outcome
The primary patient outcome is adherence to treatment choice.
Time frame: 2010-08-01 - 2011-04-01
7 secondary outcomes
satisfaction with decision.
Time frame: 2010-08-01 - 2011-04-01
self-rated health
Time frame: 2010-08-01 - 2011-04-01
anxiety
Time frame: 2010-08-01 - 2011-04-01
enablement
Time frame: 2010-08-01 - 2011-04-01
satisfaction with communication,
Time frame: 2010-08-01 - 2011-04-01
satisfaction and confidence in decision
Time frame: 2010-08-01 - 2011-04-01
number of contacts to health services
Time frame: 2010-08-01 - 2011-04-01
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 9 May 2017.
- Derived from this study: PubMed 24040920Kirkegaard P, Edwards A, Risor MB, Thomsen JL. Risk of cardiovascular disease? A qualitative study of risk interpretation among patients with high cholesterol. BMC Fam Pract. 2013 Sep 16;14:137. doi: 10.1186/1471-2296-14-137.
- Derived from this study: PubMed 23113909Kirkegaard P, Risor MB, Edwards A, Junge AG, Thomsen JL. Speaking of risk, managing uncertainty: decision-making about cholesterol-reducing treatment in general practice. Qual Prim Care. 2012;20(4):245-52.
- Derived from this study: PubMed 20860820Kirkegaard P, Edwards AG, Hansen B, Hansen MD, Jensen MS, Lauritzen T, Risoer MB, Thomsen JL. The RISAP-study: a complex intervention in risk communication and shared decision-making in general practice. BMC Fam Pract. 2010 Sep 22;11:70. doi: 10.1186/1471-2296-11-70.
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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.
Janus L Thomsen, MD, PhD principal investigator
University of Aarhus
Questions about this trial
What is this clinical trial studying?
A study testing Training programme in people with High Cholesterol and Cardiovascular Disease, run by University of Aarhus.
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 2 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 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary patient outcome is adherence to treatment choice. (time frame: 2010-08-01 - 2011-04-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01187056, which also lists 3 linked publications.
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 9 May 2017.