StrokeLAS-2NCT01417585
A Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
A study testing Client-centered ADL intervention and Usual ADL intervention in people with Stroke and Physical Disability, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Physical Disability, Multiple Disability
- What is being tested?
- Client-centered ADL intervention and Usual ADL intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 280 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2009to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- < 3 months after stroke
- Dependent in at least two activities of daily living
- Able to understand instructions
- Referred to a participating rehabilitation unit.
Who cannot join
- Diagnosed dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life satisfaction during the first year after stroke. In addition use of health services, caregiver burden and significant others' life satisfaction will be studied. Study design, methods and power analysis are based on our previous pilot study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3 months after stroke, dependent in at least two activities of daily living, understand instructions and referred to a participating rehabilitation unit. Data are collected at baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In addition qualitative longitudinal studies will be performed in order to describe how CADL is integrated.
- Conditions
- Stroke, Physical Disability, Multiple Disability
- Being tested
- Client-centered ADL intervention, Usual ADL intervention
- Keywords
- Activities of daily living, Caregiver burden, Client centered, Life satisfaction, Participation, Patient satisfaction, Rehabilitation, Self rated impact of stroke, Stroke
- Medical subject headings
- Stroke, Caregiver Burden, Personal Satisfaction, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Client-centered ADL interventionBehavioural
Client-centered ADL refers to rehabilitation of activities of daily living specifically guided by the needs as expressed by the client/patient and her/his significant others, a process that specifically aims to support the client by taking the client's goals and views as the guide for the rehabilitation process.
Usual ADL interventionBehavioural
The variation of strategies and ways to conduct usual ADL rehabilitation according to the routines and praxis of the participating rehabilitation units randomized to supply the control condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived participation
Measured: 12 months
Secondary outcomes (7)
Life satisfaction
Measured: 3 and 12 months
Utilization of health care and health related services
Measured: During one year after inclusion
Fatigue
Measured: baseline, 3, 6 and 12 months
Caregiver burden
Measured: 3 and 12 months
Self rated impact of stroke
Stroke Impact Scale
Measured: 3, 6 and 12 months
Activities of daily living
Measured: baseline, 3, 6 and 12 months
Satisfaction with care
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Council for Working Life and Social Research, The Swedish Brain Foundation (Hjärnfonden), Stroke-Riksförbundet, Region Stockholm, Uppsala County Council, Sweden, Uppsala-Örebro Regional Research Council
- Responsible party
- Principal investigator, Lena von Koch, Karolinska Institutet
- Investigators
- Kerstin Tham, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417585
- Sponsor's protocol ID
- 2009/727-31/1
- Acronym
- LAS-2
- Status last verified
- Jan 2012
- First submitted
- 15 Aug 2011
- Last updated
- 16 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tistad M, Flink M, Ytterberg C, Eriksson G, Guidetti S, Tham K, von Koch L. Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention. BMJ Open. 2018 Aug 5;8(8):e022222. doi: 10.1136/bmjopen-2018-022222.
PubMed 30082359
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Client-centered Intervention Aiming to Improve Functioning in Daily Life After Stroke
- ClinicalTrials.gov ID
- NCT01417585
- Acronym / sponsor ID
- LAS-2 / 2009/727-31/1
- Conditions
- Stroke, Physical Disability, Multiple Disability
- Keywords
- Activities of daily living, Caregiver burden, Client centered, Life satisfaction, Participation, Patient satisfaction, Rehabilitation, Self rated impact of stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Council for Working Life and Social Research, The Swedish Brain Foundation (Hjärnfonden), Stroke-Riksförbundet, Region Stockholm, Uppsala County Council, Sweden, Uppsala-Örebro Regional Research Council
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Aug 2011 (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.
This is a cluster randomized controlled trial in which client-centered rehabilitation of activities of daily living (CADL) will be compared to usual rehabilitation of activities of daily living (UADL) regarding participation in activities of daily living, independence in activities of daily living and life satisfaction during the first year after stroke. In addition use of health services, caregiver burden and significant others' life satisfaction will be studied. Study design, methods and power analysis are based on our previous pilot study. Participating rehabilitation centers in the counties of Stockholm, Uppsala and Gavleborg have been randomized to supply CADL or UADL. Patients are included who are: < 3 months after stroke, dependent in at least two activities of daily living, understand instructions and referred to a participating rehabilitation unit. Data are collected at baseline, 3, 6 and 12 months. For sufficient power 280 participants will be included. In addition qualitative longitudinal studies will be performed in order to describe how CADL is integrated.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- < 3 months after stroke
- Dependent in at least two activities of daily living
- Able to understand instructions
- Referred to a participating rehabilitation unit.
Key exclusion criteria (1 listed)
- Diagnosed dementia
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 |
|---|---|---|
| Client-centered ADL interventionClient-centered ADL refers to rehabilitation of activities of daily living specifically guided by the needs as expressed by the client/patient and her/his significant others, a process that specifically aims to support the client by taking the client's goals and views as the guide for the rehabilitation process. | Behavioural | – |
| Usual ADL interventionThe variation of strategies and ways to conduct usual ADL rehabilitation according to the routines and praxis of the participating rehabilitation units randomized to supply the control condition. | Behavioural | – |
Primary outcome
Perceived participation
Time frame: 12 months
7 secondary outcomes
Life satisfaction
Time frame: 3 and 12 months
Utilization of health care and health related services
Time frame: During one year after inclusion
Fatigue
Time frame: baseline, 3, 6 and 12 months
Caregiver burden
Time frame: 3 and 12 months
Self rated impact of stroke
Time frame: 3, 6 and 12 months
Activities of daily living
Time frame: baseline, 3, 6 and 12 months
Satisfaction with care
Time frame: 3, 6 and 12 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 16 Apr 2013.
- Derived from this study: PubMed 30082359Tistad M, Flink M, Ytterberg C, Eriksson G, Guidetti S, Tham K, von Koch L. Resource use of healthcare services 1 year after stroke: a secondary analysis of a cluster-randomised controlled trial of a client-centred activities of daily living intervention. BMJ Open. 2018 Aug 5;8(8):e022222. doi: 10.1136/bmjopen-2018-022222.
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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.
Kerstin Tham, PhD study chair
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Client-centered ADL intervention and Usual ADL intervention in people with Stroke and Physical Disability, run by Karolinska Institutet at 1 site in Sweden.
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 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 16 Apr 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 Sweden. 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?
Perceived participation (time frame: 12 months). 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 NCT01417585, which also lists 1 linked publication.
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 16 Apr 2013.