Home ResidentsKODRONCT02992054
An Innovative Occupational Program Using New Technologies (KODRO) Life of Nursing
An observational study of Home Residents, run by University Hospital, Montpellier.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 months to 100 years
- Conditions the study is for
- Home Residents
- What is being tested?
- stimulating activities
- Type of treatment
- Pill or oral medicine
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Jun 2014
- Phase
- Observational
- 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 months to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Nursing home residents
Who may be able to join
- Nursing home residents
Who cannot join
- Not able to participate in the ocupational therapy using KODRO (Demential end of life ...)
About this study
Official title: 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).
Read the 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.
- Conditions
- Home Residents
- Being tested
- stimulating activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulating activitiesOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: stimulating activities | |
| Stimulating activities with usual stimulation activity program | No Stimulating activities through the use of a tactile tablet computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life: QOL-AD score: questionnaire
Measured: 6 months
Secondary outcomes (1)
Different aspects of QOL score: questionnaire
Measurement of apathy
- depression
- anxiety
- autonomy
- self-esteem
- overall well-being
- behavioral problems
- psychotropic medication use
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study startDec 2010
- Primary completionJan 2014
- Study completionJun 2014
Why it stopped: The number of patients were enough for statistic treatment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Home ResidentsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert BLAIN, MD, PHD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992054
- Sponsor's protocol ID
- 9215
- Acronym
- KODRO
- Status last verified
- Dec 2014
- First submitted
- 6 Sep 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02992054
- Acronym / sponsor ID
- KODRO / 9215
- Conditions
- Home Residents
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The number of patients were enough for statistic treatment
- Enrolment
- 239 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Dec 2016 (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.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stimulating activities with the use of tactile tablet computer | – | Other: stimulating activitiesStimulating 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 |
Who may qualify
- Ages
- 65 months to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Nursing home residents
Key inclusion criteria (1 listed)
- Nursing home residents
Key exclusion criteria (1 listed)
- Not able to participate in the ocupational therapy using KODRO (Demential end of life ...)
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 |
|---|---|---|
| stimulating activities | Other | Stimulating activities with the use of tactile tablet computer |
Primary outcome
Quality of life: QOL-AD score: questionnaire
Time frame: 6 months
1 secondary outcome
Different aspects of QOL score: questionnaire
Time frame: 6 Months
Results and safety
The study was stopped early (reason given: The number of patients were enough for statistic treatment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Home Residents
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
Not yet recruiting
A Virtual Reality Program for Nursing Home Residents With Physical Disabilities
Older Adults Institutionalized in Residential Homes
Not yet recruiting
SmartEnLite for Nursing Home Residents With Dementia
Alzheimer's Disease and Related Dementias, Alzheimer Disease and Related Dementias
Not yet recruiting
Study on the Prevention of Weight Loss Through Physical Activity Among Nursing Home Residents
Appetite Loss in Aging, Anorexia of Aging
Not yet recruiting
Feasibility Study of an Interactive Wall-Based Intervention Program for Nursing Home Residents and Patients in Long-Term Care Facilities: Mur'Aventure
Institutionalized Older Adults
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.
Hubert BLAIN, MD, PHD principal investigator
University Hospital, Montpellier
Questions about this trial
What is this clinical trial studying?
An observational study of Home Residents, run by University Hospital, Montpellier.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: The number of patients were enough for statistic treatment). Results are not available in the source record.
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?
Quality of life: QOL-AD score: questionnaire (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2016.