Cardiovascular DiseaseNCT01629654
Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
A study testing Health promotion program in people with Cardiovascular Disease and Stroke, run by University of Aarhus at 1 site in Denmark.
Trial summary
Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Stroke
- What is being tested?
- Health promotion program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Jun 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
- Patients with first ever stroke
- > 18 year
- Living in the area of Aarhus(intervention group) and patients living in the area of Holstebro (control group).
- Multidimensional Fatigue Inventory-20/Generel Fatigue > 12.
- The patient must be able to give informed consent
- Walking without person support.
- Walking aids is accepted.
Who cannot join
- Neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention)
- Other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin)
- Severe co-morbidity (including cancer, blindness or deathness)
- Not-danish speaking.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Neurology, Aarhus University Hospital
Aarhus, Central Jutland, 8000
About this study
Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Little is known about strategies addressing post-stroke fatigue and their effectiveness.
Aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.
Read the detailed description
Fatigue is a common complaint after stroke, reported by 39-72% of patients. It has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. However, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies.
Objective The aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program.
Material and Methods Intervention Mapping is the overall approach of the study. It describes a protocol for the development of theory- and evidence-based health promotion programmes.
Step 1) The program is developed based on a needs assessment. Existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review.
Step 2) The program will be tested in a pilot study (controlled trial). In addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. The control group will receive conventional treatment only.
Step 3) Evaluation of the program: Primary outcome measure will be fatigue, measured on the Multidimensional Fatigue Inventory-20. Secondary outcome measures will be identified during the development of the program. Patients will be tested at baseline, after 3 months and after 6 months. The effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.
- Conditions
- Cardiovascular Disease, Stroke
- Being tested
- Health promotion program
- Keywords
- Poststroke fatigue, Health promotion, Patient education
- Medical subject headings
- Cardiovascular Diseases, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion programBehavioural
Also called Poststroke fatigue, Complex interventions
A 13 weeks organized program:
- One group session about poststroke fatigue involving both patient and relatives
- Two personal meetings, involving both patient and relatives
- Three telephone meetings, involving only patient
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Testing of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program. Receives: Behavioral: Health promotion program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multidimensional Fatigue Inventory 20
The multidimensional Fatigue Inventory 20 is a multidimensional fatigue score covering five dimensions of fatigue: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Activity. Pathologic Fatigue is defined as a score ≥ 12 on the General Fatigue dimension.
Measured: Change from baseline in MFI-20 at 3 and 6 months
Secondary outcomes (1)
The general self-efficacy scale
The general self-efficacy scale is a scale measuring how individuals cope with distressing situations
Measured: Change from baseline in the generel self-efficacy scale at 3 and 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 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, The Novo Nordic Foundation, Aase and Ejnar Danielsens Foundation
- Responsible party
- Sponsor
- Investigators
- Marit Kirkevold, Professor, Principal investigator, University of Aarhus, Health, Nursing Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629654
- Sponsor's protocol ID
- TEA2011
- Status last verified
- Jun 2012
- First submitted
- 20 Jan 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue
- ClinicalTrials.gov ID
- NCT01629654
- Acronym / sponsor ID
- TEA2011
- Conditions
- Cardiovascular Disease, Stroke
- Keywords
- Poststroke fatigue, Health promotion, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, The Novo Nordic Foundation, Aase and Ejnar Danielsens Foundation
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jun 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.
Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Little is known about strategies addressing post-stroke fatigue and their effectiveness.
Aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.
Detailed description
Fatigue is a common complaint after stroke, reported by 39-72% of patients. It has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. However, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies.
Objective The aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program.
Material and Methods Intervention Mapping is the overall approach of the study. It describes a protocol for the development of theory- and evidence-based health promotion programmes.
Step 1) The program is developed based on a needs assessment. Existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review.
Step 2) The program will be tested in a pilot study (controlled trial). In addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. The control group will receive conventional treatment only.
Step 3) Evaluation of the program: Primary outcome measure will be fatigue, measured on the Multidimensional Fatigue Inventory-20. Secondary outcome measures will be identified during the development of the program. Patients will be tested at baseline, after 3 months and after 6 months. The effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Health promotion programTesting of the teory- and evidence based health promotion program. Patients will participate in a 13 weeks program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with first ever stroke
- > 18 year
- Living in the area of Aarhus(intervention group) and patients living in the area of Holstebro (control group).
- Multidimensional Fatigue Inventory-20/Generel Fatigue > 12.
- The patient must be able to give informed consent
Key exclusion criteria (4 listed)
- Neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention)
- Other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin)
- Severe co-morbidity (including cancer, blindness or deathness)
- Not-danish speaking.
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 |
|---|---|---|
| Health promotion programAlso: Poststroke fatigue, Complex interventionsA 13 weeks organized program: * One group session about poststroke fatigue involving both patient and relatives * Two personal meetings, involving both patient and relatives * Three telephone meetings, involving only patient | Behavioural | Lifestyle counseling |
Primary outcome
Multidimensional Fatigue Inventory 20
Time frame: Change from baseline in MFI-20 at 3 and 6 months
The multidimensional Fatigue Inventory 20 is a multidimensional fatigue score covering five dimensions of fatigue: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Activity. Pathologic Fatigue is defined as a score ≥ 12 on the General Fatigue dimension.
1 secondary outcome
The general self-efficacy scale
Time frame: Change from baseline in the generel self-efficacy scale at 3 and 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 27 Jun 2012.
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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.
Marit Kirkevold, Professor principal investigator
University of Aarhus, Health, Nursing Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion program in people with Cardiovascular Disease and Stroke, run by University of Aarhus 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 7 inclusion and 4 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 27 Jun 2012. 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?
Multidimensional Fatigue Inventory 20 (time frame: Change from baseline in MFI-20 at 3 and 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 27 Jun 2012.