Urinary Incontinence and Sedentary Behaviour in Nursing Homes

NCT04297904 | Completed

• 1 other identifier: ONH001
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 15

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.

Conditions

Urinary Incontinence in Old Age; Sedentary Behavior

Keywords

Nursing home; Older people; Urinary incontinence; Sedentary behaviour; Functioning

Outcome Measures

Primary Outcomes (7)

• Urinary Incontinence

  The presence of IU assessed by the Minimum Data Set (MDS) version 3.0

  January 2020 to July 2020 (cross-sectional)

• Patterns of sedentary behaviour

  Patterns of sedentary behaviour (SB) with monitors (PAL Technologies, Scotland).

  January 2020 to July 2020 (cross-sectional)

• Functional decline

  Modified (Likert 5-point scale) Barthel Index, assessed every 6 months

  January 2020 to March 2022 (longitudinal, follow-up)

• Continence decline

  Minimum Data Set (MDS) version 3.0, assessed every 6 months

  January 2020 to march 2022 (longitudinal, follow-up)

• Incidence of falls

  Prospective register of falls (date, place and consequence/s)

  January 2020 to March 2022 (longitudinal, follow-up)

• Hospitalizations

  Prospective register of hospitalizations (date and cause)

  January 2020 to March 2022 (longitudinal, follow-up)

• Mortality

  Prospective register of deaths (date and cause)

  January 2020 to March 2022 (longitudinal, follow-up)

Secondary Outcomes (30)

• Sociodemographic variables

  January 2020 to July 2020

• Lower urinary tract symptoms

  January 2020 to July 2020

• Faecal incontinence

  January 2020 to July 2020

• Intake of liquids and diuretic drinks

  January 2020 to July 2020

• Handgrip strength

  January 2020 to July 2020

Interventions

Sedentary behaviour BEHAVIORAL

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.

Urinary Incontinence DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Subjects in coma or palliative care (prognosis of short life).
• Voluntary participation in the study.
• Be diagnosed with UI for at least 6 months
• Be able to express themselves verbally.
• Voluntary participation in the study
• Caring for older people with UI for at least 6 months.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Glasgow Caledonian University: collaborator
• University Ramon Llull: collaborator
• Universidade Federal do Rio Grande do Norte: collaborator

Study Sites (15)

Residència Sant Gabriel. Nursing home

Centelles, Barcelona, 08540, Spain

Location

Casal Oller. Nursing home

els Hostalets de Balenyà, Barcelona, 08550, Spain

Location

Casal de la Santa Creu. Nursing home

L'Esquirol, Barcelona, 08511, Spain

Location

Residència Cantonigròs. Nursing home

L'Esquirol, Barcelona, 08511, Spain

Location

Residència Aura. Nursing home

Manlleu, Barcelona, 08560, Spain

Location

Residència els Tells. Nursing home

Montesquiu, Barcelona, 08585, Spain

Location

Els Munts. Nursing home

Sant Boi de Lluçanès, Barcelona, 08201, Spain

Location

Fundació Gallifa. Nursing home

Sant Hipòlit de Voltregà, Barcelona, 08215, Spain

Location

Els Bons Amics. Nursing home

Seva, Barcelona, 08269, Spain

Location

Hotel Residència el Prat. Nursing home

Tona, Barcelona, 08551, Spain

Location

Residència Prudenci. Nursing home

Tona, Barcelona, 08551, Spain

Location

Residencia Rocapravera. Nursing home

Torelló, Barcelona, 08570, Spain

Location

Funcació Privada de Gestió Clear - Residència Centre de Dia SAITS. Nursing home

Vic, Barcelona, 08500, Spain

Location

Residencia el Nadal. Nursing home

Vic, Barcelona, 08500, Spain

Location

University of Vic - Central University of Catalonia. Facultat de Ciències de la Salut i el Benestar; Afiliation with the M3O research group

Vic, Barcelona, 08500, Spain

Location

Related Publications (2)

• Escriba-Salvans A, Rierola-Fochs S, Farres-Godayol P, Molas-Tuneu M, de Souza DLB, Skelton DA, Goutan-Roura E, Minobes-Molina E, Jerez-Roig J. Risk factors for developing symptomatic COVID-19 in older residents of nursing homes: A hypothesis-generating observational study. J Frailty Sarcopenia Falls. 2023 Jun 1;8(2):74-82. doi: 10.22540/JFSF-08-074. eCollection 2023 Jun.

  PMID: 37275659 DERIVED

• Farres-Godayol P, Jerez-Roig J, Minobes-Molina E, Yildirim M, Goutan-Roura E, Coll-Planas L, Escriba-Salvans A, Molas-Tuneu M, Moreno-Martin P, Rierola-Fochs S, Rierola-Colomer S, Romero-Mas M, Torres-Moreno M, Naudo-Molist J, Bezerra de Souza DL, Booth J, Skelton DA, Gine-Garriga M. Urinary incontinence and sedentary behaviour in nursing home residents in Osona, Catalonia: protocol for the OsoNaH project, a multicentre observational study. BMJ Open. 2021 Apr 20;11(4):e041152. doi: 10.1136/bmjopen-2020-041152.

  PMID: 33879481 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Urinary Incontinence

Condition Hierarchy (Ancestors)

Behavior; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eduard Minobes Molina, PhD

  M3O

  PRINCIPAL INVESTIGATOR

• Javier Jerez-Roig, PhD, Professor

  M3O

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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)

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 6, 2020
• Study Start: January 10, 2020
• Primary Completion: March 10, 2022
• Study Completion: March 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

ES (15)