Stroke, IschemicNCT03648957
Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack
A study testing Lifestyle counselling and Activity tracker in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Transient Ischemic Attack
- What is being tested?
- Lifestyle counselling and Activity tracker
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to 28 Feb 2021
- 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
- Male or female, age ≥ 18 years old
- Hospitalized patients with TIA (ICD-10 G45.9) or stroke (ICD-10 I61, I63, I64) with a Scandinavian Stroke Scale of 45-58. Diagnosis must by confirmed by a neurologist
- Discharge to their own home
- Able to give a valid written consent
Who cannot join
- Severe barriers to communication
- Not able to use a telephone
- Severe disability prior to the stroke (WHO Performance Status >2; mobilised less than 50 % of the day)
- Requiring specialized rehabilitation
- Active abuse of alcohol or narcotics
- Severe psychiatric illness (affective disease, dementia, schizophrenia, anxiety)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study
Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in patients with acute minor stroke or transient ischemic attack who are discharged home.
Read the detailed description
Stroke is a significant cause of morbidity, mortality, and loss of independence worldwide. In Denmark 12,000 people have a stroke per year. About one fourth of patients admitted with a stroke have had previous strokes or transient ischemic attack (TIA). The risk of recurrent stroke is highest in the first weeks and decreasing with time.
In the last decades there has been an increased focus on the importance of health behaviour in the public and among patients in relations to prevention of vascular diseases. There is solid scientific evidence of the harmful effects of lifestyle factors, such as smoking, physical inactivity, and alcohol overuse.
Hypertension is one of the leading risk factors for vascular diseases, including stroke and TIA. Lowering of the blood pressure is therefore an essential part of stroke treatment. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication is highly recommended in patients with minor stroke and TIA.
There is still a lack of knowledge about how to support patients in making suitable choices to prevent recurrence and progression of their disease. Previous research has shown varying results and it is therefore difficult to point out any specific intervention or element of interventions which would be feasible to implement in clinical practice.
The hypothesis of the study is that early client-centred patient counselling with repeated follow-up sessions after discharge can reduce the blood pressure through smoking cessation, physical activity, and improved adherence to preventive medication in patients with minor stroke and transient ischemic attacks compared to simple encouragement to lifestyle change.
The overall purpose of our research is to develop effective and clinically feasible interventions to prevent recurrent strokes in patients with minor stroke and transient ischemic attacks, and identify unmet needs in the newly discharged patients and their relatives.
The PhD study will comprise of 1) a randomized feasibility trial (n=40) aiming to test a combined behavioural and clinical intervention with follow-up sessions post-discharge with 3-4 weeks intervals in 12 weeks on reducing blood pressure in patients with minor stroke and transient ischemic attack 2) a qualitative study to explore the patients attitudes and experiences towards medicine adherence, lifestyle changes, social support, and self-efficacy.
- Being tested
- Lifestyle counselling, Usual care, Activity tracker
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counsellingBehavioural
First behavioral counselling session will be conducted before discharge and follow-up session will be offered with 3-4 weeks intervals either by telephone or in the outpatient clinic.
Usual careBehavioural
Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.
Activity trackerDevice
Participants are encouraged to wear a activity tracker to monitor their physical activity
| Study group | Role | What they receive |
|---|---|---|
| Behavioral intervention | Experimental | Usual stroke service care plus additional lifestyle counselling focusing on smoking cessation, physical activity, and adherence to preventive medication. Regular follow-up sessions (3-4 weeks intervals). Physical activity is monitors by an activity tracker. Receives: Behavioral: Lifestyle counselling; Device: Activity tracker |
| Usual care | Active comparator | Usual stroke service care; including computed tomography brain scan, neurological evaluation, and relevant cardiological/vascular evaluation (48-72 hour telemetry, echocardiography, carotic ultrasound imaging). At discharge all patients will receive written and verbal encouragement to a healthy lifestyle. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Change in resting systolic blood pressure from baseline to three months follow-up
Measured: At baseline (0 weeks) and end of intervention (12 weeks)
Secondary outcomes (2)
Recruitment rate
Proportion of eligible patients included in the study
Measured: 12 weeks
Adherence rate
Proportion of included participants adhering to and completing the study protocol
Measured: From baseline (0 weeks) until the end of intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2018
- Primary completion8 Apr 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Metropolitan University College
- Responsible party
- Sponsor
- Investigators
- Thomas Christensen, MD, Study director, Department of Neurology, Nordsjællands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648957
- Sponsor's protocol ID
- H-17040484
- Status last verified
- Mar 2021
- First submitted
- 14 Aug 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liljehult J, Molsted S, Moller T, Overgaard D, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke or transient ischemic attack: a randomized controlled pilot study. Pilot Feasibility Stud. 2024 Mar 22;10(1):50. doi: 10.1186/s40814-024-01478-4.
PubMed 38519983Liljehult J, Molsted S, Moller T, Overgaard D, Adamsen L, Jarden M, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke and transient ischemic attack: study protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2020 Mar 25;6:40. doi: 10.1186/s40814-020-00583-4. eCollection 2020.
PubMed 32226634
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack: A Randomized Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT03648957
- Acronym / sponsor ID
- H-17040484
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Metropolitan University College
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 28 Aug 2018 (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.
Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in patients with acute minor stroke or transient ischemic attack who are discharged home.
Detailed description
Stroke is a significant cause of morbidity, mortality, and loss of independence worldwide. In Denmark 12,000 people have a stroke per year. About one fourth of patients admitted with a stroke have had previous strokes or transient ischemic attack (TIA). The risk of recurrent stroke is highest in the first weeks and decreasing with time.
In the last decades there has been an increased focus on the importance of health behaviour in the public and among patients in relations to prevention of vascular diseases. There is solid scientific evidence of the harmful effects of lifestyle factors, such as smoking, physical inactivity, and alcohol overuse.
Hypertension is one of the leading risk factors for vascular diseases, including stroke and TIA. Lowering of the blood pressure is therefore an essential part of stroke treatment. Smoking cessation, physical activity, and adherence to antihypertensive and antithrombotic medication is highly recommended in patients with minor stroke and TIA.
There is still a lack of knowledge about how to support patients in making suitable choices to prevent recurrence and progression of their disease. Previous research has shown varying results and it is therefore difficult to point out any specific intervention or element of interventions which would be feasible to implement in clinical practice.
The hypothesis of the study is that early client-centred patient counselling with repeated follow-up sessions after discharge can reduce the blood pressure through smoking cessation, physical activity, and improved adherence to preventive medication in patients with minor stroke and transient ischemic attacks compared to simple encouragement to lifestyle change.
The overall purpose of our research is to develop effective and clinically feasible interventions to prevent recurrent strokes in patients with minor stroke and transient ischemic attacks, and identify unmet needs in the newly discharged patients and their relatives.
The PhD study will comprise of 1) a randomized feasibility trial (n=40) aiming to test a combined behavioural and clinical intervention with follow-up sessions post-discharge with 3-4 weeks intervals in 12 weeks on reducing blood pressure in patients with minor stroke and transient ischemic attack 2) a qualitative study to explore the patients attitudes and experiences towards medicine adherence, lifestyle changes, social support, and self-efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral intervention | Experimental | Behavioral: Lifestyle counselling, Device: Activity trackerUsual stroke service care plus additional lifestyle counselling focusing on smoking cessation, physical activity, and adherence to preventive medication. Regular follow-up sessions (3-4 weeks intervals). Physical activity is monitors by an activity tracker. |
| Usual care | Active comparator | Behavioral: Usual careUsual stroke service care; including computed tomography brain scan, neurological evaluation, and relevant cardiological/vascular evaluation (48-72 hour telemetry, echocardiography, carotic ultrasound imaging). At discharge all patients will receive written and verbal encouragement to a healthy lifestyle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age ≥ 18 years old
- Hospitalized patients with TIA (ICD-10 G45.9) or stroke (ICD-10 I61, I63, I64) with a Scandinavian Stroke Scale of 45-58. Diagnosis must by confirmed by a neurologist
- Discharge to their own home
- Able to give a valid written consent
Key exclusion criteria (6 listed)
- Severe barriers to communication
- Not able to use a telephone
- Severe disability prior to the stroke (WHO Performance Status >2; mobilised less than 50 % of the day)
- Requiring specialized rehabilitation
- Active abuse of alcohol or narcotics
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 counsellingFirst behavioral counselling session will be conducted before discharge and follow-up session will be offered with 3-4 weeks intervals either by telephone or in the outpatient clinic. | Behavioural | Behavioral intervention |
| Usual careUsual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle. | Behavioural | Usual care |
| Activity trackerParticipants are encouraged to wear a activity tracker to monitor their physical activity | Device | Behavioral intervention |
Primary outcome
Systolic blood pressure
Time frame: At baseline (0 weeks) and end of intervention (12 weeks)
Change in resting systolic blood pressure from baseline to three months follow-up
2 secondary outcomes
Recruitment rate
Time frame: 12 weeks
Adherence rate
Time frame: From baseline (0 weeks) until the end of intervention (12 weeks)
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 3 Mar 2021.
- Derived from this study: PubMed 38519983Liljehult J, Molsted S, Moller T, Overgaard D, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke or transient ischemic attack: a randomized controlled pilot study. Pilot Feasibility Stud. 2024 Mar 22;10(1):50. doi: 10.1186/s40814-024-01478-4.
- Derived from this study: PubMed 32226634Liljehult J, Molsted S, Moller T, Overgaard D, Adamsen L, Jarden M, Christensen T. Lifestyle counselling as secondary prevention in patients with minor stroke and transient ischemic attack: study protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2020 Mar 25;6:40. doi: 10.1186/s40814-020-00583-4. eCollection 2020.
- 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.
Thomas Christensen, MD study director
Department of Neurology, Nordsjællands Hospital
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 counselling and Activity tracker in people with Stroke, Ischemic and Stroke Hemorrhagic, run by Nordsjaellands Hospital at 1 site in Denmark.
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 4 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: finished, as of the sponsor's last update on 3 Mar 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 Denmark. 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?
Systolic blood pressure (time frame: At baseline (0 weeks) and end of intervention (12 weeks)). 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 NCT03648957, which also lists 2 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 3 Mar 2021.