Technologies for Participatory Medicine and Health Promotion in the Elderly Population

Study Overview
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Brief Summary
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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.

Official Title
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Technologies for Participatory Medicine and Health Promotion in the Elderly Population

Conditions
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Aging, Age Problem

Intervention / Treatment
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* Other: Physical activities program
* Other: Relaxation training
* Other: Training of the pelvic floor
* Behavioral: Counseling about occupational performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urinary Incontinence<br>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<br>* 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.<br>Other: Training of the pelvic floor<br>* 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<br>Behavioral: Counseling about occupational performance<br>* 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.<br>|
| Experimental: Insomnia<br>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<br>* 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.<br>Other: Relaxation training<br>* 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.<br>Behavioral: Counseling about occupational performance<br>* 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.<br>|
| Experimental: Risk of falls<br>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<br>* 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.<br>Behavioral: Counseling about occupational performance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elderly, Quality of life, Wearables, Urinary incontinence, Insomnia, Risk of falls