- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02992054
An Innovative Occupational Program Using New Technologies (KODRO) Life of Nursing (KODRO)
December 9, 2016 updated by: University Hospital, Montpellier
Randomized Controlled Trial for Assessing the Effects Resulting From an Innovative Occupational Program Using New Technologies (KODRO) on Nursing Home Residents' Quality of Life (Pilot Study)
Randomized controlled trial for assessing the effects resulting from an innovative occupational program using new technologies (KODRO) on nursing home residents' quality of life
Context : improving quality of life (QOL) for the nursing homes residents (NHR) is a national priority (2010 report from French ANESM).
Study Overview
Detailed Description
KODRO stimulation program makes available stimulating activities through the use of a tactile tablet computer.
These tablets are linked to an internet-based service platform The project main objective is to demonstrate by way of a randomized controlled trial the significance of the improvement of residents' QOL achieved by 2 one-hour KODRO sessions per week during 6 months (KODRO nursing homes) when compared with the usual stimulation activity program (nursing homes "controls") (difference for the QOL-AD score > 2 points).At last, the objective of the study is also observational, i.e. to determine the quality of life of NHR at baseline, in its differents aspects.Subjects & methods Analysis will be conducted to compare quantitative parameters at the beginning of the trial to verify the comparability of the two groups and of the mean average change between parameters measured at baseline, 3 months, and 6 months in both groups.
Study Type
Observational
Enrollment (Actual)
239
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Nursing home residents
Description
Inclusion Criteria:
- Nursing home residents
Exclusion Criteria:
- Not able to participate in the ocupational therapy using KODRO (Demential end of life ...)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stimulating activities with the use of tactile tablet computer
Stimulating activities through the use of a tactile tablet computer.
These tablets are linked to an internet-based service platform and offer a very easy and intuitive interaction for the user, even when this person is suffering from a moderate cognitive and/or physical impairment.
|
|
|
Stimulating activities with usual stimulation activity program
No Stimulating activities through the use of a tactile tablet computer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life: QOL-AD score: questionnaire
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Different aspects of QOL score: questionnaire
Time Frame: 6 Months
|
Measurement of apathy
|
6 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 6, 2016
First Submitted That Met QC Criteria
December 9, 2016
First Posted (Estimate)
December 14, 2016
Study Record Updates
Last Update Posted (Estimate)
December 14, 2016
Last Update Submitted That Met QC Criteria
December 9, 2016
Last Verified
December 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 9215
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.