Residents's Frailty in Temporary AccommodationFRAQOLNCT05659706
Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
An observational study of Residents's Frailty in Temporary Accommodation and Residents's Quality of Life in Temporary Accommodation, run by Jeanne et Leon Developpement at 1 site in France.
Trial summary
The management of frailty is a difficulty in the Temporary Accommodation Residences. Frailty represents a risk of reducing the activities of the elderly person. Jeanne \& Léon Développement® offers an activity program that integrates several dimensions (physical and/or nutritional and/or social and/or psychological). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Residents's Frailty in Temporary Accommodation, Residents's Quality of Life in Temporary Accommodation
- What is being tested?
- cognitive evaluations and non cognitive evaluations
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2022to 20 Apr 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will focus on elderly people (men and women) living in temporary accommodation in the Résidence Les Tamaris. It will take place in the residents' living quarters.
Who may be able to join
- Aged 60 years and over
- Participant who has been living in temporary accommodation at the Résidence Les Tamaris for a maximum of 72 hours
- Visual, auditory and oral or written abilities in French sufficient to complete the assessments and participate in the Jeanne \& Léon® Program activities
- Agrees to participate in the study and follow-ups for up to six months after the end of the activity program/temporary residence
- Non-opposition accompanied by the information note co-signed by the investigator and the resident participating in the study, or the family member or the designated trusted person (if applicable)
- Must be affiliated to a social security plan
Who cannot join
- Refusal to participate by the resident, family member or designated support person
- Communication difficulties, sensory and/or motor deficits
- Medical contraindication
- Participant already included in another research protocol
- Person under legal protection
Trial locations and contacts
1 site in 1 country.
Valentine DUTHEILLET DE LAMOTHE contact
valentine.dutheillet-de-lamothe@gerontopole-paysdelaloire.fr
France1 site, 1 recruiting
- Recruiting
Résidence les Tamaris- Jeanne et Léon Développement
Bois-de-Céné, 85710
Christophe BEAUVAIS, christophe.beauvais@jeanneetleon.com
Nathalie BEAUVAIS, nathaliebeauvais@puvlestamaris.fr
About this study
The management of frailty is a difficulty in the Temporary Accommodation Residences. Frailty represents a risk of reducing the activities of the elderly person. Jeanne \& Léon Développement® offers an activity program that integrates several dimensions (physical and/or nutritional and/or social and/or psychological). To obtain the expected benefit, effect of the Jeanne \& Léon® activities program on the residents's frailty and quality of life in temporary accommodation, the activity of at least one of these approaches is used as a global stimulant and thus activates the remaining skills to help fight against the frailty syndrome. In order to do this, the framework of the temporary accommodation, the group dynamics and the presence of a professional facilitator ensure the conditions for adherence to the program and promote the realization of stimulating activities.
The phenomenon of activation initiated during the residential activity program can lead to an improvement in the components of frailty which is maintained over time. This will be assessed in terms of the occurrence of events after the activity program has been followed.
Read the detailed description
The clinical assessment will be performed by the investigating physician.
Initial follow-up: Fragility and Quality of Life assessment is carried out by the trained nursing staff (doctor, nurse) of the Résidence Les Tamaris. The clinical assessment will include screening for thymic disorders. All experimenters will be specifically trained in the protocol and GCP beforehand.
V0 (inclusion visit carried out within 72 hours after admission to the residence): inclusion after information and non-opposition, then randomization into the control group or the intervention group V1 (initial assessment visit performed within 96 hours after admission to the residence): initial assessment of the resident V2 (V1+ 21 days +/- 1 day: end of main study visit): final evaluation of the main study.
In case of discharge from the Residence: validation of the contact information and the follow-up telephone schedule of the participant.
Post-program follow-up: identification of intercurrent events by the Residence staff
VS1 (V2 + 1 Month), SV2 (V2 + 3 Months): interview of participants by on-site follow-up or telephone call VS3 (V2 + 6 Months): on-site follow-up or final phone call.
- Conditions
- Residents's Frailty in Temporary Accommodation, Residents's Quality of Life in Temporary Accommodation
- Being tested
- cognitive evaluations and non cognitive evaluations
- Keywords
- Frailty, Quality of life, Health event
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive evaluations and non cognitive evaluationsOther
Mini Mental State Examination Charlson Comorbidity Index Katz Index ICOPE step 1 The 15-item geriatric depression scale (GDS-15) Medical Outcomes Study Short Form 36 (SF-36) Short Physical Performance Battery ( SPPB)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: "intervention" group, named "Group 3+" | attend at least three workshops per week Receives: Other: cognitive evaluations and non cognitive evaluations | |
| Arm 2: "control" group, named "Group 0-1" | not participate in the activities program or will attend a maximum of one workshop per week. Receives: Other: cognitive evaluations and non cognitive evaluations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire).
The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire).
The Short Physical Performance Battery (SPPB) composite test and Short Form 36 (SF-36) self questionnaire will be assessed within 96 hours of admission to the residence, prior to program implementation, and then 3 weeks after the initial assessment
SPPB: minimum value = 0 ; maximum value = 12 SPPB 0-6= Low performance SPPB 7-9 =Intermediate intermédiaires SPPB 10-12 =High performance
SF36: minimum value = 0 ; maximum value = 100
Measured: 8 months
Secondary outcomes (6)
Evolution of each item of the scores Short Form 36 self questionnaire
Evolution of each item of the scores Short Form 36 self questionnaire
Measured: 15 months
Evolution of each item of the scores Short Physical Performance Battery (SPPB) composite test
Evolution of each item of the scores Short Physical Performance Battery (SPPB) composite test
Measured: 15 months
Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)
Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)
no scores: answers yes/no to different items
Measured: 15 months
Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program
Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program The objective is to estimate the frequency of occurrence of intercurrent health events of the composite score FRAQOL
Measured: 15 months
Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
Measured: 15 months
Use of the ICOPE screening questionnaire responses as a descriptive element of the study population and analysis of a potential predictive relationship on the 6-month outcome.
Use of the ICOPE screening questionnaire responses as a descriptive element of the study population and analysis of a potential predictive relationship on the 6-month outcome.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start20 Oct 2022
- Primary completion20 Jan 2024 (estimated)
- Study completion20 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Residents's Frailty in Temporary AccommodationStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeanne et Leon Developpement
- Sponsor type
- University, hospital or other
- Collaborators
- Gerontopôle des Pays de la Loire
- Responsible party
- Sponsor
- Investigators
- Gilles BERRUT, Pr, Study director, Gérontopôle des Pays de la Loire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659706
- Sponsor's protocol ID
- 21-S01
- Acronym
- FRAQOL
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tinetti ME, Fried T. The end of the disease era. Am J Med. 2004 Feb 1;116(3):179-85. doi: 10.1016/j.amjmed.2003.09.031.
PubMed 14749162Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):387-90. doi: 10.1684/pnv.2011.0311. French.
PubMed 22182814Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
PubMed 9672396EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med A. 1981 May;15(3 Pt 1):221-9. doi: 10.1016/0271-7123(81)90005-5. No abstract available.
PubMed 6973203Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira Vd, Mazzardo O, Campos Wd. Association between physical activity and quality of life in the elderly: a systematic review, 2000-2012. Braz J Psychiatry. 2014 Jan-Mar;36(1):76-88. doi: 10.1590/1516-4446-2012-0895. Epub 2014 Jan 17.
PubMed 24554274Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h.
PubMed 7775992Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
PubMed 9817119de Lira CAB, Taveira HV, Rufo-Tavares W, Amorim ADS, Ferreira LMC, Andrade MS, Vancini RL. Engagement in a Community Physical Activity Program and Its Effects Upon the Health-Related Quality of Life of Elderly People: A Cross-Sectional Study. Value Health Reg Issues. 2018 Dec;17:183-188. doi: 10.1016/j.vhri.2018.10.002. Epub 2018 Nov 9.
PubMed 30419539Rosenberg T, Montgomery P, Hay V, Lattimer R. Using frailty and quality of life measures in clinical care of the elderly in Canada to predict death, nursing home transfer and hospitalisation - the frailty and ageing cohort study. BMJ Open. 2019 Nov 12;9(11):e032712. doi: 10.1136/bmjopen-2019-032712.
PubMed 31722953Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
PubMed 15031310Marzetti E, Calvani R, Tosato M, Cesari M, Di Bari M, Cherubini A, Broccatelli M, Savera G, D'Elia M, Pahor M, Bernabei R, Landi F; SPRINTT Consortium. Physical activity and exercise as countermeasures to physical frailty and sarcopenia. Aging Clin Exp Res. 2017 Feb;29(1):35-42. doi: 10.1007/s40520-016-0705-4. Epub 2017 Feb 8.
PubMed 28181204Landi F, Abbatecola AM, Provinciali M, Corsonello A, Bustacchini S, Manigrasso L, Cherubini A, Bernabei R, Lattanzio F. Moving against frailty: does physical activity matter? Biogerontology. 2010 Oct;11(5):537-45. doi: 10.1007/s10522-010-9296-1. Epub 2010 Aug 10.
PubMed 20697813Bauman A, Merom D, Bull FC, Buchner DM, Fiatarone Singh MA. Updating the Evidence for Physical Activity: Summative Reviews of the Epidemiological Evidence, Prevalence, and Interventions to Promote "Active Aging". Gerontologist. 2016 Apr;56 Suppl 2:S268-80. doi: 10.1093/geront/gnw031.
PubMed 26994266
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Jeanne et Léon Program® on the Residents's Frailty in Temporary
- ClinicalTrials.gov ID
- NCT05659706
- Acronym / sponsor ID
- FRAQOL / 21-S01
- Conditions
- Residents's Frailty in Temporary Accommodation, Residents's Quality of Life in Temporary Accommodation
- Keywords
- Frailty, Quality of life, Health event
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jeanne et Leon DeveloppementUniversity, hospital or other
- Collaborators
- Gerontopôle des Pays de la Loire
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 20 Apr 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- 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.
The management of frailty is a difficulty in the Temporary Accommodation Residences. Frailty represents a risk of reducing the activities of the elderly person. Jeanne \& Léon Développement® offers an activity program that integrates several dimensions (physical and/or nutritional and/or social and/or psychological). To obtain the expected benefit, effect of the Jeanne \& Léon® activities program on the residents's frailty and quality of life in temporary accommodation, the activity of at least one of these approaches is used as a global stimulant and thus activates the remaining skills to help fight against the frailty syndrome. In order to do this, the framework of the temporary accommodation, the group dynamics and the presence of a professional facilitator ensure the conditions for adherence to the program and promote the realization of stimulating activities.
The phenomenon of activation initiated during the residential activity program can lead to an improvement in the components of frailty which is maintained over time. This will be assessed in terms of the occurrence of events after the activity program has been followed.
Detailed description
The clinical assessment will be performed by the investigating physician.
Initial follow-up: Fragility and Quality of Life assessment is carried out by the trained nursing staff (doctor, nurse) of the Résidence Les Tamaris. The clinical assessment will include screening for thymic disorders. All experimenters will be specifically trained in the protocol and GCP beforehand.
V0 (inclusion visit carried out within 72 hours after admission to the residence): inclusion after information and non-opposition, then randomization into the control group or the intervention group V1 (initial assessment visit performed within 96 hours after admission to the residence): initial assessment of the resident V2 (V1+ 21 days +/- 1 day: end of main study visit): final evaluation of the main study.
In case of discharge from the Residence: validation of the contact information and the follow-up telephone schedule of the participant.
Post-program follow-up: identification of intercurrent events by the Residence staff
VS1 (V2 + 1 Month), SV2 (V2 + 3 Months): interview of participants by on-site follow-up or telephone call VS3 (V2 + 6 Months): on-site follow-up or final phone call.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: "intervention" group, named "Group 3+" | – | Other: cognitive evaluations and non cognitive evaluationsattend at least three workshops per week |
| Arm 2: "control" group, named "Group 0-1" | – | Other: cognitive evaluations and non cognitive evaluationsnot participate in the activities program or will attend a maximum of one workshop per week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will focus on elderly people (men and women) living in temporary accommodation in the Résidence Les Tamaris. It will take place in the residents' living quarters.
Key inclusion criteria (6 listed)
- Aged 60 years and over
- Participant who has been living in temporary accommodation at the Résidence Les Tamaris for a maximum of 72 hours
- Visual, auditory and oral or written abilities in French sufficient to complete the assessments and participate in the Jeanne \& Léon® Program activities
- Agrees to participate in the study and follow-ups for up to six months after the end of the activity program/temporary residence
- Non-opposition accompanied by the information note co-signed by the investigator and the resident participating in the study, or the family member or the designated trusted person (if applicable)
Key exclusion criteria (5 listed)
- Refusal to participate by the resident, family member or designated support person
- Communication difficulties, sensory and/or motor deficits
- Medical contraindication
- Participant already included in another research protocol
- Person under legal protection
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 |
|---|---|---|
| cognitive evaluations and non cognitive evaluationsMini Mental State Examination Charlson Comorbidity Index Katz Index ICOPE step 1 The 15-item geriatric depression scale (GDS-15) Medical Outcomes Study Short Form 36 (SF-36) Short Physical Performance Battery ( SPPB) | Other | Arm 1: "intervention" group, named "Group 3+", Arm 2: "control" group, named "Group 0-1" |
Primary outcome
The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire).
Time frame: 8 months
The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire). The Short Physical Performance Battery (SPPB) composite test and Short Form 36 (SF-36) self questionnaire will be assessed within 96 hours of admission to the residence, prior to program implementation, and then 3 weeks after the initial assessment SPPB: minimum value = 0 ; maximum value = 12 SPPB 0-6= Low performance SPPB 7-9 =Intermediate intermédiaires SPPB 10-12 =High performance SF36: minimum value = 0 ; maximum value = 100
6 secondary outcomes
Evolution of each item of the scores Short Form 36 self questionnaire
Time frame: 15 months
Evolution of each item of the scores Short Physical Performance Battery (SPPB) composite test
Time frame: 15 months
Evolution of each item of the Step 1 of ICOPE(Integrated Care for Older People)
Time frame: 15 months
Evolution of intercurrent health events of the composite score FRAQOL at one, three and six months after the end of the program
Time frame: 15 months
Estimation of the incremental cost associated with the occurrence of intercurrent events up to six months after program completion
Time frame: 15 months
Use of the ICOPE screening questionnaire responses as a descriptive element of the study population and analysis of a potential predictive relationship on the 6-month outcome.
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Background: PubMed 14749162Tinetti ME, Fried T. The end of the disease era. Am J Med. 2004 Feb 1;116(3):179-85. doi: 10.1016/j.amjmed.2003.09.031.
- Background: PubMed 22182814Rolland Y, Benetos A, Gentric A, Ankri J, Blanchard F, Bonnefoy M, de Decker L, Ferry M, Gonthier R, Hanon O, Jeandel C, Nourhashemi F, Perret-Guillaume C, Retornaz F, Bouvier H, Ruault G, Berrut G. [Frailty in older population: a brief position paper from the French society of geriatrics and gerontology]. Geriatr Psychol Neuropsychiatr Vieil. 2011 Dec;9(4):387-90. doi: 10.1684/pnv.2011.0311. French.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 9672396The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
- Background: PubMed 10109801EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
- Background: PubMed 6973203Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med A. 1981 May;15(3 Pt 1):221-9. doi: 10.1016/0271-7123(81)90005-5. No abstract available.
- Background: PubMed 24554274Vagetti GC, Barbosa Filho VC, Moreira NB, Oliveira Vd, Mazzardo O, Campos Wd. Association between physical activity and quality of life in the elderly: a systematic review, 2000-2012. Braz J Psychiatry. 2014 Jan-Mar;36(1):76-88. doi: 10.1590/1516-4446-2012-0895. Epub 2014 Jan 17.
- Background: PubMed 7775992Perneger TV, Leplege A, Etter JF, Rougemont A. Validation of a French-language version of the MOS 36-Item Short Form Health Survey (SF-36) in young healthy adults. J Clin Epidemiol. 1995 Aug;48(8):1051-60. doi: 10.1016/0895-4356(94)00227-h.
- Background: PubMed 9817119Leplege A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998 Nov;51(11):1013-23. doi: 10.1016/s0895-4356(98)00093-6.
- Background: PubMed 30419539de Lira CAB, Taveira HV, Rufo-Tavares W, Amorim ADS, Ferreira LMC, Andrade MS, Vancini RL. Engagement in a Community Physical Activity Program and Its Effects Upon the Health-Related Quality of Life of Elderly People: A Cross-Sectional Study. Value Health Reg Issues. 2018 Dec;17:183-188. doi: 10.1016/j.vhri.2018.10.002. Epub 2018 Nov 9.
- Background: PubMed 31722953Rosenberg T, Montgomery P, Hay V, Lattimer R. Using frailty and quality of life measures in clinical care of the elderly in Canada to predict death, nursing home transfer and hospitalisation - the frailty and ageing cohort study. BMJ Open. 2019 Nov 12;9(11):e032712. doi: 10.1136/bmjopen-2019-032712.
- Background: PubMed 15031310Fried LP, Ferrucci L, Darer J, Williamson JD, Anderson G. Untangling the concepts of disability, frailty, and comorbidity: implications for improved targeting and care. J Gerontol A Biol Sci Med Sci. 2004 Mar;59(3):255-63. doi: 10.1093/gerona/59.3.m255.
- Individual participant dataSharing planned: No
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.
Valentine DUTHEILLET DE LAMOTHE contact
valentine.dutheillet-de-lamothe@gerontopole-paysdelaloire.fr
Gilles BERRUT, Pr study director
Gérontopôle des Pays de la Loire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Residents's Frailty in Temporary Accommodation and Residents's Quality of Life in Temporary Accommodation, run by Jeanne et Leon Developpement at 1 site in France.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manon PONDJIKLI (+33975121125, manon.pondjikli@gerontopole-paysdelaloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The endpoint will be a composite score, the FRAQOL, based on a combination of functional performance assessment (Short Physical Performance Battery (SPPB) composite test) and Quality of Life (Short Form 36 (SF-36) self questionnaire). (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659706, which also lists 31 linked publications.
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 21 Dec 2022.