NCT00783055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
Last Updated

October 31, 2008

Status Verified

August 1, 2008

Enrollment Period

2.4 years

First QC Date

October 30, 2008

Last Update Submit

October 30, 2008

Conditions

Frailty

Keywords

AutonomyOlder peoplePhysically frailNursing homeIntervention study

Outcome Measures

Primary Outcomes (1)

  • The Autonomy Sub-dimension

    baseline, after 12 weeks, anfter 24 weeks

Study Arms (1)

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.

Other: Individually tailored programmes

Interventions

Individually tailored programmesOTHER

Individualised intervention programmes based on individual wishes for daily activities

Also known as: activity, autonomy
Treatment

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Terminal stages of disease
  • MMSE-score below 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre of Applied and Clinical Excercise Sciences, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

Odense, 5000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 19040767DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Lis Puggaard, PhD

    University of Southern Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

March 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

October 31, 2008

Record last verified: 2008-08

Locations

DK(1)