Technologies for Participatory Medicine and Health Promotion in the Elderly Population

Aging Clinical Trial

— GERIATIC  

Official title:

Technologies for Participatory Medicine and Health Promotion in the Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504813
• Other study ID #: IN852A 2016/10
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Universidade da Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age Problem
• Aging

Intervention

Other:
• 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

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Universidade da Coruña	A Coruña

Sponsors (6)

Lead Sponsor	Collaborator
Universidade da Coruña	Aldaba, Cobián Clinic, Geriatros, Instituto de Investigacion Biomedica de A Coruna, Research Center on Information and Communication Technologies (CITIC)

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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. — View Citation

Badia Llach X, Castro Díaz D, Perales Cabañas L, Pena Outeriño JM, Martínez-Agulló E, Conejero Sugrañés J, Arañó Beltrán P, Marqués 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. — View 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. — View Citation

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche 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. — View Citation

Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. — View 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. — View 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. — View Citation

Ferreira CH, Barbosa PB, de Oliveira Souza F, Antônio FI, Franco MM, Bø 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. — View 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. — View Citation

Gershenfeld N, Krikorian R, Cohen D. The Internet of things. Sci Am. 2004 Oct;291(4):76-81. — View Citation

Krhut J, Zachoval R, Smith PP, Rosier PF, Valanský 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. Review. — View 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. — View 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. — View Citation

Stier-Jarmer M, Grill E, Müller 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. — View Citation

Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. — View Citation

Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Charlson Comorbidity Index	Each comorbidity category has an associated weight (from 1 to 6), based on the adjusted risk of mortality or resource use, and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.	1 month before intervention
Other	Incontinence Urinary-4 Questionnaire	This tool helps to classify the type of urinary incontinence (UI). This scale has a unique qualitative value (four different options). It is emphasized that question 1 identifies the effort of UI, while questions 2 and 3 identify the UI of urgency. Each question is answered as yes or no	1 month before intervention
Primary	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	Independence on Activities of Daily Living	Barthel Activities of Daily Living (ADL) Index: This tool is used as a simple index of independence to score the ability of a patient to care for himself, and by repeating the test periodically, to assess his improvement. The performance is assessed based on these scores: <20: total dependence, 20---40: severe dependence, 45-55: moderate dependence, and 60 or more: mild dependence.	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Gait and balance	The test is scored on the individual's ability to perform specific tasks. "Scoring of the Tinetti Assessment Tool is done on a three-point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score (12 points), an overall balance assessment score (16 points), and a combined gait and balance score (28).	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Cognitive State	Mini-Mental State Examination (MMSE): This tool has been designed to determine the "cognitive state," that is one of the study's variables. It presents six values: one for each section (Orientation, Fixation, Concentration and calculation, Memory and Language, and Construction)	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Oxford Grading Scale	This scale measures the variable of "pelvic floor contractile capacity". It has a unique numerical value (0-5), that is the result from assessment of the contractile capacity of the pelvic floor muscles	Baseline and 3 months after intervention
Secondary	Sandvick Severity Index	This test assesses the variable "urine leakage". It presents a unique numerical value and consists of two questions, one of them about the frequency with which a person has urine leakage (maximum score of 4 points) and another with reference to the amount of urine in the exhaust (maximum score of 3 points)	Baseline and 3 months after intervention
Secondary	24-Hour Pad Test	This tool allows to measure the "amount of urine". This scale has three values (net weight of the napkin/diaper, weight with urine and weight difference).	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Pelvic Floor Muscle Assessment: PERFECT Scheme	The tool PERFECT Scheme allows to assess the "pelvic floor musculature". PERFECT is an acronym with P representing power (or pressure, a measure of strength using a manometric perineometer), E = endurance, R = repetitions, F = fast contractions, and ECT = every contraction timed.	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	International Consultation on Incontinence Questionnaire (Short Form)	Self-administered questionnaire that qualifies the "symptoms and quality of life" in both male and female adult patients with symptoms of urine loss. It has 6 items, Score is 0 - 21 with a higher score indicating greater severity.	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Oviedo Sleep Questionnaire	This scale allows assess the "sleep satisfaction". It consists of 13 items with three values: one for each section (sleep satisfaction, insomnia and hypersomnia). Each item is scored from 1 to 5, except for item 1 which is scored from 1 to 7. The subscale of insomnia ranges from 9 to 45 points; the higher the score the greater the severity.	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Pittsburgh Sleep Quality Assessment	The measure consists of 19 individual items, creating seven components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Timed Get Up and Go Test	A simple test used to assess a person's mobility and requires both static and dynamic balance	Baseline and 6 months later (during intervention). Three months after intervention
Secondary	Falls Efficacy Scale International	The tool measures "the level of concern about falling" during social and physical activities inside and outside the home. Individuals are asked to rate, on a four-point Likert scale,their concerns aboutthe possibility offalling when performing 16 activities.The scores are added up to calculate a total score that ranges from 16 to 64 for the FES-I and 8 to 28 for the short FES-I. A higher score indicates a greater fear of falls	Baseline and 6 months later (during intervention). Three months after intervention

External Links

•   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
•   Alberich T, Barranco Carrillo A, Funes Jime´nez E, Espadas Alca´zar MA, Melo´n Gonza´lez O. Intervencio´n social y sanitaria con mayores manual para el trabajo con la 3a. y 4a. edad.
•   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):
•   Barry A, McGwire S PK. Global AgeWatch Index 2015 [Internet]. Age International, editor. 2015
•   EQ-5D instruments - EQ-5D
•   Giner P, Cetina C, Fons J, Pelechano V. Developing Mobile Workflow Support in the Internet of Things
•   Instituto Nacional de Estadistica. (Spanish Statistical Office)
•   Milla´n Calenti JC. Gerontologi´a y geriatri´a : valoracio´n e intervencio´n [Internet]. Editorial Me´dica Panamericana; 2011
•   Universidad Pública de Navarra. ViviFrail
•   World Health Organization. ICD-10 Version:2008 [Internet]. WHO, editor. Genebra; 2008
•   World Health Orgnization. WHO | Falls [Internet]. WHO. World Health Organization; 2018