Technologies for Participatory Medicine and Health Promotion in the Elderly Population
- Conditions
- AgingAge Problem
- Interventions
- Other: Physical activities programOther: Relaxation trainingBehavioral: Counseling about occupational performanceOther: Training of the pelvic floor
- Registration Number
- NCT03504813
- Lead Sponsor
- Universidade da Coruña
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insomnia Relaxation training 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. Insomnia Physical activities program 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 Physical activities program 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 Urinary Incontinence Physical activities program 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 Risk of falls Counseling about occupational performance 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 Urinary Incontinence Training of the pelvic floor 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 Urinary Incontinence Counseling about occupational performance 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 Counseling about occupational performance 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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
Trial Locations
- Locations (1)
Universidade da Coruña
🇪🇸A Coruña, Spain