- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00783055
Autonomy Among Physically Frail Older People in Nursing Homes
Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Odense, Denmark, 5000
- Centre of Applied and Clinical Excercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Terminal stages of disease
- MMSE-score below 16
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment
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.
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Individualised intervention programmes based on individual wishes for daily activities
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The Autonomy Sub-dimension
Time Frame: baseline, after 12 weeks, anfter 24 weeks
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baseline, after 12 weeks, anfter 24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Lis Puggaard, PhD, University of Southern Denmark
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2004-1-52G
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