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Technologies for Participatory Medicine and Health Promotion in the Elderly Population (GERIATIC)

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ClinicalTrials.gov Identifier: NCT03504813
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Geriatros
Research Center on Information and Communication Technologies (CITIC)
Instituto de Investigacion Biomedica de A Coruna
Aldaba
Cobián Clinic
Information provided by (Responsible Party):
Javier Pereira, 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.


Condition or disease Intervention/treatment Phase
Aging Age Problem Other: Physical activities program Other: Relaxation training Other: Training of the pelvic floor Behavioral: Counseling about occupational performance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technologies for Participatory Medicine and Health Promotion in the Elderly Population
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: Urinary Incontinence

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
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.

Other: Training 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

Behavioral: Counseling 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.

Experimental: Insomnia

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
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.

Other: Relaxation 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.

Behavioral: Counseling 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.

Experimental: Risk of falls

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
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.

Behavioral: Counseling 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   One of interventions that are carrying on in the present study, is focused in prevention and treatment the urinary incontinence. For that, a pelvic floor training is implementing. For that, specific inclusion criteria has been established: the training is doing with a sample of women older than 65 years old.
Accepts Healthy Volunteers:   No
Criteria

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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504813


Locations
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Spain
Universidade da Coruña
A Coruña, Spain, 15006
Sponsors and Collaborators
Universidade da Coruña
Geriatros
Research Center on Information and Communication Technologies (CITIC)
Instituto de Investigacion Biomedica de A Coruna
Aldaba
Cobián Clinic
Investigators
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Principal Investigator: Javier P Pereira, PhD University of A Coruña
  Study Documents (Full-Text)

Documents provided by Javier Pereira, Universidade da Coruña:

Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Javier Pereira, Proffesor PhD, Universidade da Coruña
ClinicalTrials.gov Identifier: NCT03504813     History of Changes
Other Study ID Numbers: IN852A 2016/10
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Pereira, Universidade da Coruña:
Elderly
Quality of life
Wearables
Urinary incontinence
Insomnia
Risk of falls