Technologies for Participatory Medicine and Health Promotion in the Elderly Population
NCT ID: NCT03504813
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2017-03-01
2019-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Urinary Incontinence
The involuntary loss of urine through the urethra, objectively demonstrable and constituting for the person who suffers it a social and hygienic problem.
In this arm, participants will receive the following interventions: physical activities program, training of the pelvic floor and counseling about occupational performance
Physical activities program
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Training of the pelvic floor
the intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week
Counseling about occupational performance
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
Insomnia
A condition characterized by an unsatisfactory amount or quality of sleep which persists for a considerable period. This disorder includes difficulties for the falling and/or staying asleep and early awakening in the final phase of sleep.
In this arm, participants will receive the following interventions: physical activities program, relaxation training and counseling about occupational performance.
Physical activities program
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Relaxation training
Will take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed.
Counseling about occupational performance
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
Risk of falls
Involuntary events that cause people to lose balance and find themselves on the ground or other firm surfaces. The factor of falls can be intrinsic (related to the person) or extrinsic (derived from the activity or environment of the individual).
In this arm, participants will receive the following interventions: physical activities program, and counseling about occupational performance
Physical activities program
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Counseling about occupational performance
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
Interventions
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Physical activities program
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Relaxation training
Will take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed.
Training of the pelvic floor
the intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week
Counseling about occupational performance
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
Eligibility Criteria
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Inclusion Criteria
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
* 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.
* 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.
65 Years
ALL
No
Sponsors
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Geriatros
OTHER
Center on Information and Communication Technologies
OTHER
Instituto de Investigacion Biomedica de A Coruna
OTHER
Aldaba
UNKNOWN
Cobián Clinic
UNKNOWN
Universidade da Coruña
OTHER
Responsible Party
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Javier Pereira
Proffesor PhD
Principal Investigators
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Javier P Pereira, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade da Coruña
Locations
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Universidade da Coruña
A Coruña, , Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Barry A, McGwire S PK. Global AgeWatch Index 2015 \[Internet\]. Age International, editor. 2015
Instituto Nacional de Estadistica. (Spanish Statistical Office)
World Health Organization. ICD-10 Version:2008 \[Internet\]. WHO, editor. Genebra; 2008
World Health Orgnization. WHO \| Falls \[Internet\]. WHO. World Health Organization; 2018
Alberich T, Barranco Carrillo A, Funes Jiménez E, Espadas Alcázar MA, Melón González O. Intervención social y sanitaria con mayores manual para el trabajo con la 3a. y 4a. edad.
Millán Calenti JC. Gerontología y geriatría : valoración e intervención \[Internet\]. Editorial Médica Panamericana; 2011
Giner P, Cetina C, Fons J, Pelechano V. Developing Mobile Workflow Support in the Internet of Things
Aceytuno M, Ascensión E, Miralles R, Prado B, Riera M, Roqueta C et al. Guía de buena práctica clínica en Geriatría. Incontinencia urinaria \[Internet\]. SEGG, editor. Barcelona; 2008
Universidad Pública de Navarra. ViviFrail
Babes ' J, Gonllez ' MP, Vallejo J, S\&z3 J, Gibert4 J, Ayuso5 JL, et al. S162 PI Affective disorders and antidepressants m\] Oviedo Sleep Questionnaire (QSQ):
Other Identifiers
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IN852A 2016/10
Identifier Type: -
Identifier Source: org_study_id
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