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| Name | Class |
|---|---|
| Geriatros | OTHER |
| Center on Information and Communication Technologies | OTHER |
| Instituto de Investigacion Biomedica de A Coruna | OTHER |
| Aldaba |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Specific criteria for each research line:
Urinary incontinence:
Insomnia:
a) Diagnosis of insomnia and/or hypersomnia.
Risk of falls:
Exclusion Criteria:
For the research line on urinary incontinence, several specific exclusion criteria have been established:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Javier P Pereira, PhD | Universidade da Coruña | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade da Coruña | A Coruña | 15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11857671 | Background | 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. | |
| 15487673 |
| Label | URL |
|---|---|
| Barry A, McGwire S PK. Global AgeWatch Index 2015 \[Internet\]. Age International, editor. 2015 | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 23, 2018 | Apr 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012064 | Relaxation Therapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| UNKNOWN |
| Cobián Clinic | UNKNOWN |
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|
| 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. |
|
| 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 |
|
| 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. |
|
| Baseline and 6 months later (during intervention). Three months after intervention |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 27440100 | 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. |
| 12623619 | 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. |
| 21042699 | 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. |
| 3042746 | 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. |
| 3944402 | 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. |
| 1202204 | 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. |
| 7722560 | 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. |
| 21497247 | 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. |
| 10679830 | 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. |
| 10488609 | 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. |
| 23797972 | 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. |
| 2748771 | 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. |
| 1991946 | 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. |
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| 29768372 | Derived | 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. |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |