Clinical trial NCT03504813: Technologies for Participatory Medicine and Health Promotion in the Elderly Population
Official title: Technologies for Participatory Medicine and Health Promotion in the Elderly Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Age Problem
Keywords: Elderly
Quality of life
Wearables
Urinary incontinence
Insomnia
Risk of falls
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
Collaborators: name: Geriatros
name: Center on Information and Communication Technologies
name: Instituto de Investigacion Biomedica de A Coruna
name: Aldaba
name: Cobián Clinic
First posted: 2018-04-20
Enrollment: 57
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. The focus of this study is the quality of life of the elderly in relation to these three factors: risk of falls, urinary incontinence, and insomnia.

Objective: The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors.

Methods and Analysis: The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain).

It is a prospective and longitudinal study, with a temporary series design of a "quasi-experimental" type that evaluates the effect of an intervention in one given population by doing assessments pre- and post-intervention, but there is no comparison with a control group.

The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants' occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective.


Eligibility criteria: Inclusion Criteria:

* People 65 years of age or older.

Specific criteria for each research line:

* Urinary incontinence:

  1. To have stress, urgency or mixed urinary incontinence
  2. To be a woman
* Insomnia:

  a) Diagnosis of insomnia and/or hypersomnia.
* Risk of falls:

  1. To have a previous history of falls in the last 6-12 months.
  2. To present risk of falling and/or fear of falling.
  3. To have independence in locomotion.

Exclusion Criteria:

* Showing cognitive deterioration from moderate to very severe (Mini-Examination Cognitive minor of 20 points).
* Having severe, acute complications in health that prevent assiduity in attending interventions.
* Diagnosis of conditions and/or pathologies in which physical activity is contraindicated (mainly cardiorespiratory diseases).
* Being in the final stage of a terminal illness.
* Bing in a situation of request for transfer to another center.
* Having a temporary stay in elderly residence.
* Having a situation of legal incapacity.

For the research line on urinary incontinence, several specific exclusion criteria have been established:

* Having functional urinary incontinence because that type is related to cognitive deterioration, urinary infection, polypharmacy, psychological problems, endocrinopathy, mobility restriction, and fecal incontinence.
* Having undergone surgery in the pelvic floor area.
* Uterine prolapse, cystocele and/or rectocele (levels 3-4).
* No control of the pelvic floor.

Primary outcomes:
measure: Changes in the quality of life
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
Secondary outcomes:
measure: Independence on Activities of Daily Living
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Gait and balance
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Cognitive State
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Oxford Grading Scale
timeFrame: Baseline and 3 months after intervention
measure: Sandvick Severity Index
timeFrame: Baseline and 3 months after intervention
measure: 24-Hour Pad Test
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Pelvic Floor Muscle Assessment: PERFECT Scheme
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: International Consultation on Incontinence Questionnaire (Short Form)
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Oviedo Sleep Questionnaire
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Pittsburgh Sleep Quality Assessment
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Timed Get Up and Go Test
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
measure: Falls Efficacy Scale International
timeFrame: Baseline and 6 months later (during intervention). Three months after intervention
Other outcomes:
measure: Charlson Comorbidity Index
timeFrame: 1 month before intervention
measure: Incontinence Urinary-4 Questionnaire
timeFrame: 1 month before intervention
Locations:
city: A Coruña
country: Spain
facility: Universidade da Coruña
Study officials:
affiliation: University of A Coruña
name: Javier P Pereira, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
citation: Gershenfeld N, Krikorian R, Cohen D. The Internet of things. Sci Am. 2004 Oct;291(4):76-81. doi: 10.1038/scientificamerican1004-76. No abstract available.
citation: Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
citation: Davies A, De Souza LH, Frank AO. Changes in the quality of life in severely disabled people following provision of powered indoor/outdoor chairs. Disabil Rehabil. 2003 Mar 18;25(6):286-90. doi: 10.1080/0963828021000043734.
citation: Stier-Jarmer M, Grill E, Muller M, Strobl R, Quittan M, Stucki G. Validation of the comprehensive ICF Core Set for patients in geriatric post-acute rehabilitation facilities. J Rehabil Med. 2011 Jan;43(2):102-12. doi: 10.2340/16501977-0617.
citation: Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
citation: Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
citation: Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
citation: Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
citation: Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
citation: Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-45. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g.
citation: Badia Llach X, Castro Diaz D, Perales Cabanas L, Pena Outerino JM, Martinez-Agullo E, Conejero Sugranes J, Arano Beltran P, Marques Queimadelos A, Roset Gamisans M, Perulero Escobar N. [The development and preliminary validation of the IU-4 questionnaire for the clinical classification of urinary incontinence]. Actas Urol Esp. 1999 Jul-Aug;23(7):565-72. Spanish.
citation: Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
citation: Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
citation: Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
citation: Delbaere K, Close JC, Mikolaizak AS, Sachdev PS, Brodaty H, Lord SR. The Falls Efficacy Scale International (FES-I). A comprehensive longitudinal validation study. Age Ageing. 2010 Mar;39(2):210-6. doi: 10.1093/ageing/afp225. Epub 2010 Jan 8.
citation: Nieto-Riveiro L, Groba B, Miranda MC, Concheiro P, Pazos A, Pousada T, Pereira J. Technologies for participatory medicine and health promotion in the elderly population. Medicine (Baltimore). 2018 May;97(20):e10791. doi: 10.1097/MD.0000000000010791.