Technologies for Participatory Medicine and Health Promotion in the Elderly Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Changes in the quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Changes in the quality of life
时间窗: 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.
次要结局
- Independence on Activities of Daily Living(Baseline and 6 months later (during intervention). Three months after intervention)
- Gait and balance(Baseline and 6 months later (during intervention). Three months after intervention)
- Cognitive State(Baseline and 6 months later (during intervention). Three months after intervention)
- Oxford Grading Scale(Baseline and 3 months after intervention)
- Sandvick Severity Index(Baseline and 3 months after intervention)
- 24-Hour Pad Test(Baseline and 6 months later (during intervention). Three months after intervention)
- Pelvic Floor Muscle Assessment: PERFECT Scheme(Baseline and 6 months later (during intervention). Three months after intervention)
- International Consultation on Incontinence Questionnaire (Short Form)(Baseline and 6 months later (during intervention). Three months after intervention)
- Oviedo Sleep Questionnaire(Baseline and 6 months later (during intervention). Three months after intervention)
- Pittsburgh Sleep Quality Assessment(Baseline and 6 months later (during intervention). Three months after intervention)
- Timed Get Up and Go Test(Baseline and 6 months later (during intervention). Three months after intervention)
- Falls Efficacy Scale International(Baseline and 6 months later (during intervention). Three months after intervention)
研究者
Javier Pereira
Proffesor PhD
Universidade da Coruña