Technologies for Participatory Medicine and Health Promotion in the Elderly Population

NCT03504813 | Completed

• 1 other identifier: IN852A 2016/10
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Age Problem

Keywords

Elderly; Quality of life; Wearables; Urinary incontinence; Insomnia; Risk of falls

Outcome Measures

Primary Outcomes (1)

• Changes in the quality of life

  The variable will be determined with EuroQol-5D-5L. This descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

  Baseline and 6 months later (during intervention). Three months after intervention

Secondary Outcomes (12)

• Independence on Activities of Daily Living

  Baseline and 6 months later (during intervention). Three months after intervention

• Gait and balance

  Baseline and 6 months later (during intervention). Three months after intervention

• Cognitive State

  Baseline and 6 months later (during intervention). Three months after intervention

• Oxford Grading Scale

  Baseline and 3 months after intervention

• Sandvick Severity Index

  Baseline and 3 months after intervention

Other Outcomes (2)

• Charlson Comorbidity Index

  1 month before intervention

• Incontinence Urinary-4 Questionnaire

  1 month before intervention

Study Arms (3)

Urinary Incontinence

EXPERIMENTAL

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

Other: Physical activities program; Other: Training of the pelvic floor; Behavioral: Counseling about occupational performance

Insomnia

EXPERIMENTAL

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.

Other: Physical activities program; Other: Relaxation training; Behavioral: Counseling about occupational performance

Risk of falls

EXPERIMENTAL

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

Other: Physical activities program; Behavioral: Counseling about occupational performance

Interventions

Physical activities program OTHER

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.

Insomnia; Risk of falls; Urinary Incontinence

Relaxation training OTHER

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.

Insomnia

Training of the pelvic floor OTHER

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

Urinary Incontinence

Counseling about occupational performance BEHAVIORAL

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; Risk of falls; Urinary Incontinence

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: One of interventions that are carrying on in the present study, is focused in prevention and treatment the urinary incontinence. For that, a pelvic floor training is implementing. For that, specific inclusion criteria has been established: the training is doing with a sample of women older than 65 years old.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• People 65 years of age or older.
• Specific criteria for each research line:
• Urinary incontinence:
• To have stress, urgency or mixed urinary incontinence
• To be a woman
• Insomnia:
• a) Diagnosis of insomnia and/or hypersomnia.
• Risk of falls:
• To have a previous history of falls in the last 6-12 months.
• To present risk of falling and/or fear of falling.
• To have independence in locomotion.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Geriatros: collaborator
• Center on Information and Communication Technologies: collaborator
• Instituto de Investigacion Biomedica de A Coruna: collaborator
• Aldaba: collaborator
• Cobián Clinic: collaborator

Study Sites (1)

Universidade da Coruña

A Coruña, 15006, Spain

Location

Related Publications (17)

• 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.

  PMID: 11857671 BACKGROUND

• 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.

  PMID: 15487673 BACKGROUND

• 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.

  PMID: 27440100 BACKGROUND

• 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.

  PMID: 12623619 BACKGROUND

• 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.

  PMID: 21042699 BACKGROUND

• 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.

  PMID: 3042746 BACKGROUND

• 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.

  PMID: 3944402 BACKGROUND

• 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.

  PMID: 1202204 BACKGROUND

• 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.

  PMID: 7722560 BACKGROUND

• 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.

  PMID: 21497247 BACKGROUND

• 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.

  PMID: 10679830 BACKGROUND

• 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.

  PMID: 10488609 BACKGROUND

• 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.

  PMID: 23797972 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 20061508 BACKGROUND

• 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.

  PMID: 29768372 DERIVED

Related Links

• 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):

MeSH Terms

Conditions

Urinary Incontinence; Sleep Initiation and Maintenance Disorders

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

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; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Javier P Pereira, PhD

  Universidade da Coruña

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffesor PhD

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 20, 2018
• Study Start: March 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2019
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)