Autonomy Among Physically Frail Older People in Nursing Homes

Frailty Clinical Trial

Official title:

Autonomy Among Physically Frail Older People in Nursing Homes: a Study Protocol for an Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783055
• Other study ID #: 2004-1-52G
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: October 30, 2008
• Start date: March 2005
• Est. completion date: August 2007

Study information

• Verified date: August 2008
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Frailty

Intervention

Other:
• Individually tailored programmes
Individualised intervention programmes based on individual wishes for daily activities

Locations

Country	Name	City	State
Denmark	Centre of Applied and Clinical Excercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Autonomy Sub-dimension		baseline, after 12 weeks, anfter 24 weeks	No