Age Problem, Aging
Conditions
Keywords
Elderly, Quality of life, Wearables, Urinary incontinence, Insomnia, Risk of falls
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.
Interventions
OTHERPhysical 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.
OTHERRelaxation 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.
OTHERTraining 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
BEHAVIORALCounseling 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.
Sponsors
Geriatros
Center on Information and Communication Technologies
Instituto de Investigacion Biomedica de A Coruna
Aldaba
Cobián Clinic
Universidade da Coruña
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the quality of life | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Independence on Activities of Daily Living | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
| Gait and balance | Baseline and 6 months later (during intervention). Three months after intervention | 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). |
| Cognitive State | Baseline and 6 months later (during intervention). Three months after intervention | 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) |
| Oxford Grading Scale | Baseline and 3 months after intervention | 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 |
| Sandvick Severity Index | Baseline and 3 months after intervention | 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) |
| 24-Hour Pad Test | Baseline and 6 months later (during intervention). Three months after intervention | 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). |
| Timed Get Up and Go Test | Baseline and 6 months later (during intervention). Three months after intervention | A simple test used to assess a person's mobility and requires both static and dynamic balance |
| Falls Efficacy Scale International | Baseline and 6 months later (during intervention). Three months after intervention | 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 |
| Pelvic Floor Muscle Assessment: PERFECT Scheme | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
| International Consultation on Incontinence Questionnaire (Short Form) | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
| Oviedo Sleep Questionnaire | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
| Pittsburgh Sleep Quality Assessment | Baseline and 6 months later (during intervention). Three months after intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Charlson Comorbidity Index | 1 month before intervention | 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. |
| Incontinence Urinary-4 Questionnaire | 1 month before intervention | 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 |
Countries
Spain
Outcome results
None listed