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

Universidade da Coruña

Status: Completed

Conditions: Aging; Age Problem

Treatments: Other: Training of the pelvic floor; Behavioral: Counseling about occupational performance; Other: Relaxation training; Other: Physical activities program

Study type: Interventional

Funder types: Other

Identifiers

NCT03504813

IN852A 2016/10

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Urinary Incontinence

Experimental group

Description:

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

Treatment:

Other: Training of the pelvic floor

Other: Physical activities program

Behavioral: Counseling about occupational performance

Insomnia

Experimental group

Description:

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.

Treatment:

Other: Physical activities program

Behavioral: Counseling about occupational performance

Other: Relaxation training

Risk of falls

Experimental group

Description:

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

Treatment:

Other: Physical activities program

Behavioral: Counseling about occupational performance