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NCT Number: NCT03504813

Technologies for Participatory Medicine and Health Promotion in the Elderly Population

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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Key information

Conditions

Aging Age Problem Dyssomnias Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Urinary Incontinence Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade da Coruña

A Coruña, 15006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in the quality of life

    Time frame: 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 outcomes

  1. Independence on Activities of Daily Living

    Time frame: 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.

  2. Gait and balance

    Time frame: 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).

  3. Cognitive State

    Time frame: 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)

  4. Oxford Grading Scale

    Time frame: 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

  5. Sandvick Severity Index

    Time frame: 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)

  6. 24-Hour Pad Test

    Time frame: 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).

  7. Pelvic Floor Muscle Assessment: PERFECT Scheme

    Time frame: 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.

  8. International Consultation on Incontinence Questionnaire (Short Form)

    Time frame: 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.

  9. Oviedo Sleep Questionnaire

    Time frame: 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.

  10. Pittsburgh Sleep Quality Assessment

    Time frame: 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.

  11. Timed Get Up and Go Test

    Time frame: 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

  12. Falls Efficacy Scale International

    Time frame: 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

Other outcomes

  1. Charlson Comorbidity Index

    Time frame: 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.

  2. Incontinence Urinary-4 Questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Collaborators

  • Aldaba
  • Center on Information and Communication Technologies
  • Cobián Clinic
  • Geriatros
  • Instituto de Investigacion Biomedica de A Coruna

Registry information

Acronym: GERIATIC

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 20, 2018
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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