FrailtyNCT00783055
Autonomy Among Physically Frail Older People in Nursing Homes
A study testing Individually tailored programmes in people with Frailty, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Individually tailored programmes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2005to Aug 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged 65 years or older
- All kinds of diseases leading to physical frailty
- Dependent on assistance in minimum one P-ADL activity
- Able to understand verbal instructions
- Willing to participate
- Expected to live in the nursing home during the 24 weeks
- Both men and women
Who cannot join
- Terminal stages of disease
- MMSE-score below 16
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Applied and Clinical Excercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Odense, 5000
About this study
Official title: Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study
The purpose of this study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.
Read the detailed description
Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings perceive autonomy. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on individual wishes for daily activities.
The purpose of this study was to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people in nursing homes.
- Conditions
- Frailty
- Being tested
- Individually tailored programmes
- Keywords
- Autonomy, Older people, Physically frail, Nursing home, Intervention study
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individually tailored programmesOther
Also called activity, autonomy
Individualised intervention programmes based on individual wishes for daily activities
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 12 weeks of individually tailored intervention programmes based on participants individual wishes for daily activities e.g.ADL, mobility, social, mental or creative that they want to improve, conserve - and/or to revive. Receives: Other: Individually tailored programmes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Autonomy Sub-dimension
Measured: baseline, after 12 weeks, anfter 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startMar 2005
- Primary completionAug 2007
- Study completionAug 2007
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 FrailtyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Investigators
- Lis Puggaard, PhD, Study director, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783055
- Sponsor's protocol ID
- 2004-1-52G
- Status last verified
- Aug 2008
- First submitted
- 30 Oct 2008
- Last updated
- 31 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Andresen M, Puggaard L. Autonomy among physically frail older people in nursing home settings: a study protocol for an intervention study. BMC Geriatr. 2008 Dec 1;8:32. doi: 10.1186/1471-2318-8-32.
PubMed 19040767
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study
- ClinicalTrials.gov ID
- NCT00783055
- Acronym / sponsor ID
- 2004-1-52G
- Conditions
- Frailty
- Keywords
- Autonomy, Older people, Physically frail, Nursing home, Intervention study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 31 Oct 2008 (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 study is to assess the status of perceived autonomy and to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people living in nursing homes.
Detailed description
Experiencing autonomy is recognised to promote health and well-being for all age groups. Perceived lack of control has been found to be detrimental to physical and mental health. There is a lack of evidence-based knowledge elucidating how frail older people in nursing home settings perceive autonomy. Further, there are no studies on the extent to which this perception can be influenced positively by participating in an individually tailored programme based on individual wishes for daily activities.
The purpose of this study was to evaluate the effectiveness of individually tailored programmes on perceived autonomy in physically frail older people in nursing homes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Individually tailored programmes12 weeks of individually tailored intervention programmes based on participants individual wishes for daily activities e.g.ADL, mobility, social, mental or creative that they want to improve, conserve - and/or to revive. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Aged 65 years or older
- All kinds of diseases leading to physical frailty
- Dependent on assistance in minimum one P-ADL activity
- Able to understand verbal instructions
- Willing to participate
Key exclusion criteria (2 listed)
- Terminal stages of disease
- MMSE-score below 16
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 |
|---|---|---|
| Individually tailored programmesAlso: activity, autonomyIndividualised intervention programmes based on individual wishes for daily activities | Other | Treatment |
Primary outcome
The Autonomy Sub-dimension
Time frame: baseline, after 12 weeks, anfter 24 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 31 Oct 2008.
- Derived from this study: PubMed 19040767Andresen M, Puggaard L. Autonomy among physically frail older people in nursing home settings: a study protocol for an intervention study. BMC Geriatr. 2008 Dec 1;8:32. doi: 10.1186/1471-2318-8-32.
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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.
Lis Puggaard, PhD study director
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individually tailored programmes in people with Frailty, run by University of Southern Denmark 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 2 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 31 Oct 2008. 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?
The Autonomy Sub-dimension (time frame: baseline, after 12 weeks, anfter 24 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 NCT00783055, 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 31 Oct 2008.