PsychosocialPhase 1/2NCT01912014
Psychosocial Wellbeing Following Stroke
A Phase 1/2 study testing Psychosocial support and counselling in people with Psychosocial and Narrative, run by University of Oslo at 1 site in Norway.
Trial summary
The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial, Narrative, Coping
- What is being tested?
- Psychosocial support and counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2007to Dec 2011
- Phase
- Phase 1/2
- 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
- 18 years old or above
- acute stroke
- 4-8 weeks poststroke
Who cannot join
- Other serious disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care
The purpose of this feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.
- Conditions
- Psychosocial, Narrative, Coping, Quality of Life
- Being tested
- Psychosocial support and counselling
- Keywords
- stroke, psychosocial, intervention, quality of life
- Medical subject headings
- Narration, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial support and counsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial support and counselling | Experimental | There is only one arm as this is a pilot and feasibility study. Receives: Behavioral: Psychosocial support and counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Measured: baseline and 2 weeks after end of intervention
Secondary outcomes (1)
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Measured: baseline and 12 months after end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2007
- Primary completionApr 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsychosocialStudies 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 1/2
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marit Kirkevold, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912014
- Sponsor's protocol ID
- 2.2007.37 (REK)
- Other IDs
- 16369 (Social science data)
- Status last verified
- Jul 2013
- First submitted
- 24 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kirkevold M, Bronken BA, Martinsen R, Kvigne K. Promoting psychosocial well-being following a stroke: developing a theoretically and empirically sound complex intervention. Int J Nurs Stud. 2012 Apr;49(4):386-97. doi: 10.1016/j.ijnurstu.2011.10.006. Epub 2011 Nov 1.
PubMed 22051438Bronken BA, Kirkevold M. Between the lines: generating good qualitative data in studies involving persons with aphasia. ANS Adv Nurs Sci. 2013 Apr-Jun;36(2):E14-28. doi: 10.1097/ANS.0b013e318290200a.
PubMed 23644268Bronken BA, Kirkevold M, Martinsen R, Wyller TB, Kvigne K. Psychosocial well-being in persons with aphasia participating in a nursing intervention after stroke. Nurs Res Pract. 2012;2012:568242. doi: 10.1155/2012/568242. Epub 2012 Jul 22.
PubMed 22888417Kirkevold M, Martinsen R, Bronken BA, Kvigne K. Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study. BMC Psychol. 2014 Feb 3;2(1):4. doi: 10.1186/2050-7283-2-4. eCollection 2014.
PubMed 25566379
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Wellbeing Following Stroke: Developing and Testing a Psychosocial Nursing Intervention for Primary Care
- ClinicalTrials.gov ID
- NCT01912014
- Acronym / sponsor ID
- 2.2007.37 (REK)
- Conditions
- Psychosocial, Narrative, Coping, Quality of Life
- Keywords
- stroke, psychosocial, intervention, quality of life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Jul 2013 (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 feasibility study is to develop and initially test a dialogue-based psychosocial intervention aimed at promoting coping and psychosocial wellbeing following an acute stroke. The intervention is carried out by primary care registered nurses or other appropriate health professionals. The intervention included persons with and without aphasia.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychosocial support and counselling | Experimental | Behavioral: Psychosocial support and counsellingThere is only one arm as this is a pilot and feasibility study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or above
- acute stroke
- 4-8 weeks poststroke
Key exclusion criteria (1 listed)
- Other serious disease
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 |
|---|---|---|
| Psychosocial support and counselling | Behavioural | Psychosocial support and counselling |
Primary outcome
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Time frame: baseline and 2 weeks after end of intervention
1 secondary outcome
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39)
Time frame: baseline and 12 months after end of intervention
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 30 Jul 2013.
- Background: PubMed 22051438Kirkevold M, Bronken BA, Martinsen R, Kvigne K. Promoting psychosocial well-being following a stroke: developing a theoretically and empirically sound complex intervention. Int J Nurs Stud. 2012 Apr;49(4):386-97. doi: 10.1016/j.ijnurstu.2011.10.006. Epub 2011 Nov 1.
- Results publication: PubMed 23644268Bronken BA, Kirkevold M. Between the lines: generating good qualitative data in studies involving persons with aphasia. ANS Adv Nurs Sci. 2013 Apr-Jun;36(2):E14-28. doi: 10.1097/ANS.0b013e318290200a.
- Results publication: PubMed 22888417Bronken BA, Kirkevold M, Martinsen R, Wyller TB, Kvigne K. Psychosocial well-being in persons with aphasia participating in a nursing intervention after stroke. Nurs Res Pract. 2012;2012:568242. doi: 10.1155/2012/568242. Epub 2012 Jul 22.
- Derived from this study: PubMed 25566379Kirkevold M, Martinsen R, Bronken BA, Kvigne K. Promoting psychosocial wellbeing following stroke using narratives and guided self-determination: a feasibility study. BMC Psychol. 2014 Feb 3;2(1):4. doi: 10.1186/2050-7283-2-4. eCollection 2014.
Related trials for Psychosocial
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Enrolling by invitation
This Study Tests the Development and Efficacy of a Kindness Focused Intervention on University Students in Islamabad. It Aims to See the Impact of This Intervention on the Psychosocial Well-being of These Emerging Adults.
Mental Health, Psychological Wellbeing
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Recruiting
At-home Breast Oncology Care Delivered With E-health Solutions
Patient Engagement, Patient Activation
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 Phase 1/2 study testing Psychosocial support and counselling in people with Psychosocial and Narrative, run by University of Oslo at 1 site in Norway.
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 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 30 Jul 2013. 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 Norway. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in Stroke and Aphasia Quality of Life (SAQOL-39) (time frame: baseline and 2 weeks after end of intervention). 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 NCT01912014, which also lists 4 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 30 Jul 2013.