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Urinary Incontinence and Sedentary Behaviour in Nursing Homes (OsoNaH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04297904
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : May 19, 2020
Sponsor:
Collaborators:
Glasgow Caledonian University
University Ramon Llull
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Javier Jerez Roig, University of Vic - Central University of Catalonia

Brief Summary:

The increase of the older adult population in the past years has generated an important impact on chronic conditions and geriatric syndromes like dementia, falls and urinary incontinence (UI). To better understand IU seems warranted because of its socioeconomic and health impact. Nursing home (NH) residents are the frailest segment of our population, with very low physical activity levels and highly sedentary. Several studies had shown that physical activity levels and time and patterns of sedentary behaviour (SB) are independent risk factors for many health issues. As far as the investigators know, there is no evidence supporting the relation between IU and SB, and no information about the incidence of IU in NH residents living in Catalonia (Spain).

This project consists of two stages: stage 1 will conduct a cross-sectional study using mixed methodology (qualitative and quantitative), and a 2-year longitudinal study (stage 2). Stage 1 has the main objective of verifying the prevalence of IU and its associated factors in NH residents in Barcelona (Spain), as well as analyse the association between IU (and their types) with SB time and patterns. In addition, the proportion of geriatric residents who receive control measures for their IU, and whether they receive SB-related interventions from health professionals of the institution will be also explored. Finally, the investigators aim to understand the experience of NH residents and the health professionals who care for them about the characteristics, burden and barriers of having IU. Stage 2 has the main objective to verify the incidence of the functional and continence decline, falls, hospitalizations and mortality, as well as their predictive factors in older care/nursing home residents in Barcelona (Spain). Specific objetives are to assess the evolution of each activity of daily living and the causes of hospitalization and death in geriatrics residents for a period of 2 years and to verify the incidence of recurrent falls (one or more falls), and analyse the consequences of falls (fractures, hospitalizations, among others) among the residents. Potential risk and protective factors for mortality due to COVID-19 and its impact on functioning and hospitalizations will also be analyzed. Finally, the stage 2 of the project aims at creating a specific instrument for the evaluation of frailty in institutionalized older people, based on the main predictive factors of functional decline.


Condition or disease Intervention/treatment
Urinary Incontinence in Old Age Sedentary Behavior Behavioral: Sedentary behaviour Diagnostic Test: Urinary Incontinence

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Study Type : Observational
Estimated Enrollment : 458 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Associations Between Urinary Incontinence, Sedentary Behaviour and Other Health-related Outcomes in Nursing Homes in Catalonia: the OsoNaH Project
Actual Study Start Date : February 20, 2020
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : January 13, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Sedentary behaviour
    To assess sedentary behaviour each participant will wear an activity monitor (PAL Technologies, Scotland). The resident will wear the monitor on their right thigh for 24 hours per day over seven days continuously.
  • Diagnostic Test: Urinary Incontinence
    The presence of IU, assessed by the Minimum Data Set (MDS) version 3.0, and used together with the International Consultation on Incontinence Questionnaire-Short Form to characterize the incontinence.


Primary Outcome Measures :
  1. Urinary Incontinence [ Time Frame: January 2020 to July 2020 (cross-sectional) ]
    The presence of IU assessed by the Minimum Data Set (MDS) version 3.0

  2. Patterns of sedentary behaviour [ Time Frame: January 2020 to July 2020 (cross-sectional) ]
    Patterns of sedentary behaviour (SB) with monitors (PAL Technologies, Scotland).

  3. Functional decline [ Time Frame: January 2020 to January 2022 (longitudinal, follow-up) ]
    Modified (Likert 5-point scale) Barthel Index, assessed every 6 months

  4. Continence decline [ Time Frame: January 2020 to January 2022 (longitudinal, follow-up) ]
    Minimum Data Set (MDS) version 3.0, assessed every 6 months

  5. Incidence of falls [ Time Frame: January 2020 to January 2022 (longitudinal, follow-up) ]
    Prospective register of falls (date, place and consequence/s)

  6. Hospitalizations [ Time Frame: January 2020 to January 2022 (longitudinal, follow-up) ]
    Prospective register of hospitalizations (date and cause)

  7. Mortality [ Time Frame: January 2020 to January 2022 (longitudinal, follow-up) ]
    Prospective register of deaths (date and cause)


Secondary Outcome Measures :
  1. Sociodemographic variables [ Time Frame: January 2020 to July 2020 ]
    Sociodemographic variables (sex, age, civil status, education level, type of institution (public versus private / concerted) and time of residence in the institution.)

  2. Lower urinary tract symptoms [ Time Frame: January 2020 to July 2020 ]
    Number and proportion of participants with lower urinary tract symptoms with the International Prostate Symptoms Score and urinary infection for the last 30 days.

  3. Faecal incontinence [ Time Frame: January 2020 to July 2020 ]
    Faecal incontinence according to Minimum Data Set version 3.0 (MDS 3.0)

  4. Intake of liquids and diuretic drinks [ Time Frame: January 2020 to July 2020 ]
    Diary

  5. Handgrip strength [ Time Frame: January 2020 to July 2020 ]
    Dynamometer (2 trials per hand)

  6. Physical performance [ Time Frame: January 2020 to July 2020 ]
    Short Physical Performance Battery (SPPB)

  7. Mobility [ Time Frame: January 2020 to July 2020 ]
    Rivermead Mobility Index

  8. Frailty [ Time Frame: January 2020 to July 2020 ]
    Clinical Frailty Scale

  9. Basic activities of daily living [ Time Frame: January 2020 to July 2020 ]
    Modified (Likert 5-point scale) Barthel Index

  10. Physical activity programs [ Time Frame: January 2020 to July 2020 ]
    What kind of physical activity programme, the frequency of the sessions weekly, the dose of exercise of each session, the duration of the whole session, who provides the session, where the session is performed and if the session is individually or in group).

  11. Incontinence programs [ Time Frame: January 2020 to July 2020 ]
    What kind of programs are being applied to control and treat urinary and faecal incontinence in nursing homes

  12. Medication intake [ Time Frame: January 2020 to July 2020 ]
    According to the Anatomical Therapeutic Chemical classification system and the Defined Daily Dose (ATC/DDD)

  13. Health conditions [ Time Frame: January 2020 to July 2020 ]
    Number and proportion of participants with chronic diseases, delirium and pressure ulcers

  14. Quality of life [ Time Frame: January 2020 to July 2020 ]
    European Quality of Life-5 Dimensions; final score for Spain ranges between 1 (full health) to -0.654 (worse outcome)

  15. Toxic habits [ Time Frame: January 2020 to July 2020 ]
    smoking and alcohol

  16. Cognitive status [ Time Frame: January 2020 to July 2020 ]
    Pfeiffer Scale, with final score ranging from 0 (normal) to 10 (total cognitive impairment)

  17. Depressive symptoms [ Time Frame: January 2020 to July 2020 ]
    15-item Yesavage Geriatric Depression Scale, with final score ranging from 0 (normal) to 15 (severe depression)

  18. Anxiety [ Time Frame: January 2020 to July 2020 ]
    Hospital Anxiety and Depression Scale (HADS), with final score ranging from 0 (normal) to 21 (severe anxiety)

  19. Number births [ Time Frame: January 2020 to July 2020 ]
    Using the NH register

  20. Type of births [ Time Frame: January 2020 to July 2020 ]
    Using the NH register

  21. Number of falls [ Time Frame: January 2020 to July 2020 ]
    During the last year, according to the NH register

  22. Nutritional status [ Time Frame: January 2020 to July 2020 ]
    Mini Nutritional Assessment Test, ranging from 0 (malnutrition) to 30 (normal)

  23. Biochemical evaluation [ Time Frame: January 2020 to July 2020 ]
    Amount of Vitamin D, albumin and pre-albumin, PCR (Protein C-Reactive) extracted from the routine analysis of the residents.

  24. Body composition [ Time Frame: January 2020 to July 2020 ]
    Percentage (%) of body fat, % of fat-free mass and % of body water assessed by a Tanita TBF-300 bioimpedance device

  25. Social network [ Time Frame: January 2020 to July 2020 ]
    Lubben Social Network Scale ranging from 0 to 30, with a higher score indicating more social engagement.

  26. Loneliness [ Time Frame: January 2020 to July 2020 ]
    6-item Gierveld Loneliness Scale ranging from 0 (not lonely) to 6

  27. COVID-19 [ Time Frame: June 2020 to January 2022 (longitudinal, follow-up) ]
    Date and result of diagnosis test/s for COVID-19 (PCR or serological antibody test)

  28. Suspected case of COVID-19 [ Time Frame: June 2020 to January 2022 (longitudinal, follow-up) ]
    In the previous 6 months, the resident had symptoms compatible with COVID-19 (cough, fever and/or breathing difficulties) without COVID-19 diagnosis test confirmation

  29. Frailty [ Time Frame: June 2020 to January 2022 (longitudinal, follow-up) ]
    Level of resident's frailty assessed with the Clinical Frailty Scale

  30. Change in medication [ Time Frame: June 2020 to January 2022 (longitudinal, follow-up) ]
    Any change in the regular medication in the last 6 months (include the name of the med, dose and the duration of treatment)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All nursing home residents, both sexes, 65 years of age or older who live in the institution permanently willing to participate in the study.
Criteria

Inclusion Criteria for the quantitative part:

  • All nursing home residents (male or female) 65 years of age or older who live in the institution permanently who voluntary will to participate in the study.

Exclusion Criteria for the quantitative part: :

  • Subjects in coma or palliative care (prognosis of short life).

Inclusion criteria for the qualitative part (residents):

  • Voluntary participation in the study.
  • Be diagnosed with UI for at least 6 months
  • Be able to express themselves verbally.

Inclusion criteria for the qualitative part (professionals):

  • Voluntary participation in the study
  • Caring for older people with UI for at least 6 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04297904


Contacts
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Contact: Javier Jerez Roig +34938 816 025 javier.jerez@uvic.cat
Contact: Norma Roda Fabregas +34938 86 33 42 ext 8320 norma.roda@uvic.cat

Locations
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Spain
Residència Sant Gabriel. Nursing home Not yet recruiting
Centelles, Barcelona, Spain, 08540
Contact: Magda Sibina, Director    +34 93.8810026    rescentelles@gmail.com   
Casal Oller. Nursing home Not yet recruiting
Els Hostalets De Balenyà, Barcelona, Spain, 08550
Contact: Isabel Salido, PT    +34 93.8898305    info@casaloller.com   
Residència Aura. Nursing home Not yet recruiting
Manlleu, Barcelona, Spain, 08560
Contact: Angels Roméu, Manager    +34 93.8520000    aromeu@chv.cat   
Residència els Tells. Nursing home Not yet recruiting
Montesquiu, Barcelona, Spain, 08585
Contact: Núria Guillén, Director    +34 93.8550026    residenciaelstells@hotmail.com   
Els Munts. Nursing home Not yet recruiting
Sant Boi de Lluçanès, Barcelona, Spain, 08201
Contact: Marisa Casamor, Director    +34 93.8578056    salut@residenciadelsmunts.com   
Fundació Gallifa. Nursing home Not yet recruiting
Sant Hipòlit de Voltregà, Barcelona, Spain, 08215
Contact: Eva Torrejon, Director    93.8502709    etorrejon@hsc.chv.cat   
Casal de la Santa Creu. Nursing home Not yet recruiting
Santa Maria De Corcó, Barcelona, Spain, 08511
Contact: Sònia Guix, Director    +34 93.8568051    sguix@fundacionhumanitate.org   
Residència Cantonigròs. Nursing home Not yet recruiting
Santa Maria De Corcó, Barcelona, Spain, 08511
Contact: Gemma Arimany, Director    +34 93.8525035    gemma.rhc@gmail.com   
Els Bons Amics. Nursing home Not yet recruiting
Seva, Barcelona, Spain, 08269
Contact: Irene Robira, Director    +34 93.8840058    rovirari@diba.cat   
Hotel Residència el Prat. Nursing home Recruiting
Tona, Barcelona, Spain, 08551
Contact: Lourdes Ponsa, Director    +34 93.8870812    direccio@residenciaprat.com   
Residència Prudenci. Nursing home Not yet recruiting
Tona, Barcelona, Spain, 08551
Contact: Glòria Expósito, Director    +34 93.8870075    info@residenciaprudenci.com   
Residencia Rocapravera. Nursing home Not yet recruiting
Torello, Barcelona, Spain, 08570
Contact: Victòria Viqué, Director    +34 93.8590239    direccio@calsavis.cat   
Funcació Privada de Gestió Clear - Residència Centre de Dia SAITS. Nursing home Not yet recruiting
Vic, Barcelona, Spain, 08500
Contact: Daniel Alonso, PT    +34 93.8895445    daniel.alonso@uvic.cat   
Residencia el Nadal. Nursing home Not yet recruiting
Vic, Barcelona, Spain, 08500
Contact: Helena Guell, PT    + 34 938894500    helena.guell@uvic.cat   
University of Vic - Central University of Catalonia. Facultat de Ciències de la Salut i el Benestar; Afiliation with the M3O research group Not yet recruiting
Vic, Barcelona, Spain, 08500
Contact: Javier Jerez Roig, Ph.D    +34 667445356    javier.jerez@uvic.cat   
Sponsors and Collaborators
University of Vic - Central University of Catalonia
Glasgow Caledonian University
University Ramon Llull
Universidade Federal do Rio Grande do Norte
Investigators
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Principal Investigator: Eduard Minobes Molina M3O
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Responsible Party: Javier Jerez Roig, Ph.D. Research Delegate of the Faculty of Health Sciences and Wellfare of University of Vic - Central University of Catalonia. Head of research group on Methodology, Methods, Models and Outcomes of Health and Social Science (M3O), University of Vic - Central University of Catalonia
ClinicalTrials.gov Identifier: NCT04297904    
Other Study ID Numbers: ONH001
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Javier Jerez Roig, University of Vic - Central University of Catalonia:
Nursing home
Older people
Urinary incontinence
Sedentary behaviour
Functioning
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders