StrokeNCT01457300
Outcome of Rehabilitation of Older People in Primary Health Care
An observational study of Stroke and Hip Fractures, run by University of Oslo at 2 sites in Norway.
Trial summary
The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care Rehabilitation Programme in Short Term Beds in Nursing Homes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Stroke, Hip Fractures, Osteoarthritis
- What is being tested?
- Rehabilitation
- How many people
- 302 participants
- Where
- 2 sitesNorway
- Study dates
- Jun 2006to Oct 2010
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The Study Populations were Disabled Older People (=>65years), with a need for Rehabilitation either Post-Acute after Hospitalisation or admitted Directly from their Own Homes and living within the Geographically small County of Vestfold, Norway.
Who may be able to join
- Both Genders
- Age=>65 Years
- Diagnoses: Stroke, Hip Fractures, Osteoarthritis, Chronic, slowly progressing Diseases, Functional Decline due to Old Age, Functional Decline due to Long Hospital Stay
- Assessed to have a Rehabilitation Potential
Who cannot join
- Age<65 Years
- Patietns with Highly Progressive Diseases
- Sunnaas ADL Index<10
- MMSE<18
- Deeply Depressed Patients with no Initiative
- Patients with Speech Dyspnoea
- Patients with unstable Angina Pectoris
- Patients with not diagnosed Cardiac Arrythmias
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Department of General Practice/General Practice Research Unit, Institute of Health and Society, University of Oslo
Oslo, Oslo, NO-0318
Prestelokka Rehabilitation Centre
Stavern, Vestfold, 3290
About this study
Official title: Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in an Inpatient District Rehabilitation Centre Versus Standard Primary Health Care Rehabilitation - An Open Comparative Observational Stdy
The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care Rehabilitation Programme in Short Term Beds in Nursing Homes.
- Conditions
- Stroke, Hip Fractures, Osteoarthritis, Chronic Disease
- Being tested
- Rehabilitation
- Keywords
- Rehabilitation outcome, Aged, Aged, 80 and over, Activities of daily living
- Medical subject headings
- Stroke, Hip Fractures, Osteoarthritis, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
Model 1: Regular Assessment of Rehabilitation Goal, Rehabilitation Plan, Weekly Multi-Disciplinary Evaluation and Adjustment of Plan, Regular use of Measurement Scales, Regular Dialog between Personnel, Patient and Relatives. Model 2: More Occasional use of the Listed Activities. Model 1 and Model 2: Physical Training and Functional ADL Training, in Groups, One by One or Self-Training.
| Study group | Role | What they receive |
|---|---|---|
| District Rehabilitation Centre (Model 1) | Patients admitted to Primary Health Care Rehabilitation, either Post-Acute from the Same District General Hospital or Directly from their Homes. They were recruited continuously at Entrance to the Rehabilitation Centre. Receives: Other: Rehabilitation | |
| Standard PHC Rehabilitation (Model 2) | Patients admitted to Standard Primary Health Care (PHC) Rehabilitation, either Post-Acute from the Same District General Hospital or Directly from their Homes. They were recruited Continuously at Entrance to the Short Term Rehabilitation Beds in Nursing Homes or at the Beginning of Rehabilitation in their Own Homes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sunnaas ADL Index
Sunnaas ADL Index measures 12 Activities of Daily Life. Each Activity has a Score from 0-3, where 0=totally dependent and 3=independent. The Total Max Score of 36 means Totally Independent.
Measured: Change from Baseline in Sunnaas ADL Index at End of Rehabilitation. Change from End of Rehabilitation in Sunnaas ADL Index at 3 months. Change from End of Rehabilitation in Sunnaas ADL Index at 18 Months
Secondary outcomes (5)
Change in Umea Life Satisfaction Checklist
A Simple and Validated Questionnaire, testing Life Satisfaction. We chose Two of the Questions: LSCa: How satisfied are you with your Life in general? LSCb: How satisfied are you with your Ability to manage your Self-Care? The Scores are 1-3=not satisfied and 4-6=satisfied
Measured: Change from End of Rehabilitation in Umea Life Satisfaction Checklist at 3 Months after Rehabilitation.
Mini Mental Status Evaluation=MMSE
MMSE measures Cognitive Function. Scores are from 0-30, where 30 indicates no Cognitive Problems.
Measured: MMSE Recorded Two Weeks into Rehabilitation
Symptom Check List 10=SCL10
SCL10 is a Questionnaire mapping Emotional Health during the Previous Week, particularly Anxiety and Depression. SCL-10 comprises Ten Questions with Scores from 1-4. The Final Score is the Total Score sum divided by Ten. Scores>1.85 indicate Severe Emotional Problems
Measured: SCL10 recorded at two Weeks into Rehabilitation
Home Care Services
The care scores were: 1:0 hour/week, 2:>0-3 hours/week, 3:>3-6 hours/week, 4:>6-9 hours/week, and 5:>9 hours/week.
Measured: Change from End of Rehabilitation in Home Care Services at Three Months after Rehabilitation
Informal Care from Relatives
Care Scores: 1:0 Hour/Week, 2:>0-3 Hours/Week, 3:>3-6 Hours/Week, 4:>6-9 Hours/Week, and 5:>9 Hours/Week.
Measured: Change in Informal Care from relatives from End of Rehabilitation at Three Months after Rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startJun 2006
- Primary completionApr 2009
- Study completionOct 2010
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 StrokeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Medical Association
- Responsible party
- Principal investigator, Inger Johansen, University of Oslo
- Investigators
- Inger Johansen, MD, Principal investigator, University of OsloMette Brekke, MD, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457300
- Sponsor's protocol ID
- PHC rehab older people
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 25 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Johansen I, Lindbaek M, Stanghelle JK, Brekke M. Effective rehabilitation of older people in a district rehabilitation centre. J Rehabil Med. 2011 Apr;43(5):461-4. doi: 10.2340/16501977-0792.
PubMed 21390482Johansen I, Lindbak M, Stanghelle JK, Brekke M. Independence, institutionalization, death and treatment costs 18 months after rehabilitation of older people in two different primary health care settings. BMC Health Serv Res. 2012 Nov 14;12:400. doi: 10.1186/1472-6963-12-400.
PubMed 23150906
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in an Inpatient District Rehabilitation Centre Versus Standard Primary Health Care Rehabilitation - An Open Comparative Observational Stdy
- ClinicalTrials.gov ID
- NCT01457300
- Acronym / sponsor ID
- PHC rehab older people
- Conditions
- Stroke, Hip Fractures, Osteoarthritis, Chronic Disease
- Keywords
- Rehabilitation outcome, Aged, Aged, 80 and over, Activities of daily living
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian Medical Association
- Study start
- Jun 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Oct 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.
The Outcome of Multi-Disciplinary, Structured Rehabilitation of Older People in a District Inpatient Rehabilitation Centre is better than in a Standard Primary Health Care Rehabilitation Programme in Short Term Beds in Nursing Homes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| District Rehabilitation Centre (Model 1) | – | Other: RehabilitationPatients admitted to Primary Health Care Rehabilitation, either Post-Acute from the Same District General Hospital or Directly from their Homes. They were recruited continuously at Entrance to the Rehabilitation Centre. |
| Standard PHC Rehabilitation (Model 2) | – | –Patients admitted to Standard Primary Health Care (PHC) Rehabilitation, either Post-Acute from the Same District General Hospital or Directly from their Homes. They were recruited Continuously at Entrance to the Short Term Rehabilitation Beds in Nursing Homes or at the Beginning of Rehabilitation in their Own Homes. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The Study Populations were Disabled Older People (=>65years), with a need for Rehabilitation either Post-Acute after Hospitalisation or admitted Directly from their Own Homes and living within the Geographically small County of Vestfold, Norway.
Key inclusion criteria (4 listed)
- Both Genders
- Age=>65 Years
- Diagnoses: Stroke, Hip Fractures, Osteoarthritis, Chronic, slowly progressing Diseases, Functional Decline due to Old Age, Functional Decline due to Long Hospital Stay
- Assessed to have a Rehabilitation Potential
Key exclusion criteria (8 listed)
- Age<65 Years
- Patietns with Highly Progressive Diseases
- Sunnaas ADL Index<10
- MMSE<18
- Deeply Depressed Patients with no Initiative
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 |
|---|---|---|
| RehabilitationModel 1: Regular Assessment of Rehabilitation Goal, Rehabilitation Plan, Weekly Multi-Disciplinary Evaluation and Adjustment of Plan, Regular use of Measurement Scales, Regular Dialog between Personnel, Patient and Relatives. Model 2: More Occasional use of the Listed Activities. Model 1 and Model 2: Physical Training and Functional ADL Training, in Groups, One by One or Self-Training. | Other | District Rehabilitation Centre (Model 1) |
Primary outcome
Change in Sunnaas ADL Index
Time frame: Change from Baseline in Sunnaas ADL Index at End of Rehabilitation. Change from End of Rehabilitation in Sunnaas ADL Index at 3 months. Change from End of Rehabilitation in Sunnaas ADL Index at 18 Months
Sunnaas ADL Index measures 12 Activities of Daily Life. Each Activity has a Score from 0-3, where 0=totally dependent and 3=independent. The Total Max Score of 36 means Totally Independent.
5 secondary outcomes
Change in Umea Life Satisfaction Checklist
Time frame: Change from End of Rehabilitation in Umea Life Satisfaction Checklist at 3 Months after Rehabilitation.
Mini Mental Status Evaluation=MMSE
Time frame: MMSE Recorded Two Weeks into Rehabilitation
Symptom Check List 10=SCL10
Time frame: SCL10 recorded at two Weeks into Rehabilitation
Home Care Services
Time frame: Change from End of Rehabilitation in Home Care Services at Three Months after Rehabilitation
Informal Care from Relatives
Time frame: Change in Informal Care from relatives from End of Rehabilitation at Three Months after Rehabilitation
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 25 Oct 2011.
- Results publication: PubMed 21390482Johansen I, Lindbaek M, Stanghelle JK, Brekke M. Effective rehabilitation of older people in a district rehabilitation centre. J Rehabil Med. 2011 Apr;43(5):461-4. doi: 10.2340/16501977-0792.
- Derived from this study: PubMed 23150906Johansen I, Lindbak M, Stanghelle JK, Brekke M. Independence, institutionalization, death and treatment costs 18 months after rehabilitation of older people in two different primary health care settings. BMC Health Serv Res. 2012 Nov 14;12:400. doi: 10.1186/1472-6963-12-400.
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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.
Inger Johansen, MD principal investigator
University of Oslo
Mette Brekke, MD, PhD study chair
University of Oslo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hip Fractures, run by University of Oslo at 2 sites 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 4 inclusion and 8 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 25 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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 in Sunnaas ADL Index (time frame: Change from Baseline in Sunnaas ADL Index at End of Rehabilitation. Change from End of Rehabilitation in Sunnaas ADL Index at 3 months. Change from End of Rehabilitation in Sunnaas ADL Index at 18 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 NCT01457300, 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 25 Oct 2011.