Older Adults Institutionalized in Residential HomesNCT05891912
Active Aging With Technological Devices
A study testing Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function) in people with Older Adults Institutionalized in Residential Homes, run by University of Extremadura at 1 site in Spain.
Trial summary
Clinical trial with users of health care centres and nursing homes in Extremadura (Spain). Inclusion criteria are: women and men over 55 years of age with a Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment) who are able to walk independently. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults Institutionalized in Residential Homes
- What is being tested?
- Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women and men over 50 years of age
- Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment)
- Independent gait
Who cannot join
- patients with severe cognitive impairment or language impairment that prevents the use of verbal communication
- No independent gait
- Severe limitation of upper limb range of movement.
Trial locations and contacts
1 site in 1 country.
Maria Trinidad Rodríguez-Dominguez, PhD contact
Spain1 site, 1 recruiting
- Recruiting
University of Extremadura
Cáceres, Extremadura, 10003
Maria Trinidad Rodriguez-Domínguez, Phd, 0034 927 257450, trdomin@unex.es
About this study
Official title: Effects of Technological Devices in Older Adults
Clinical trial with users of health care centres and nursing homes in Extremadura (Spain). Inclusion criteria are: women and men over 55 years of age with a Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment) who are able to walk independently. Exclusion criteria are: patients with severe cognitive impairment or language impairment that prevents the use of verbal communication, non-autonomous gait and severe limitation of mobility at the level of the upper limb.
Treatment schedule: 30 min sessions, twice a week during 12 weeks
Read more
- 1 session per week: 15min small TABLET and 15min LIGHTS game.
- 1 session per week: 15min TABLE TABLET and 15min game of grape harvesting.
The intervention will be carried out by occupational therapists or physiotherapists.
The intervention period and evaluations will be performed as follows:
- Training of Occupational therapists/physiotherapists: 1 week prior to the start of the intervention for.
- Week 0- Initial measurements
- Week 1-12: device interventions
- Week 13: Final measurements
- Week 17: First follow-up measurement
- Week 21: Second follow-up measurement
- Being tested
- Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)
- Keywords
- older adults,
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)Other
The treatment will be performed in 30 min sessions, twice a week during 12 weeks. the weekly sessions will include the following games:
- 1 session per week: 15min small TABLET and 15min LIGHTS game.
- 1 session per week: 15min TABLE TABLET and 15min game of VINTAGE.
| Study group | Role | What they receive |
|---|---|---|
| Technological devices intervention | Experimental | The intervention will be in individual sessions with the following technological devices and games:
* Vertical screen: game of lights and vintage game.
* Horizontal screen: cognitive function and activities of daily living games
* Tablets: cognitive function and activities of daily living games Receives: Other: Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks
The Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment.
Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Activities of daily living performance measured with the Barthel Index at 13 weeks , 17 weeks and 21 weeks
The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.2 Most studies apply the 60/61 cutting point.
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Depression level measured with the Yesavage Geriatric Depression Scale (GDS) at 13 weeks , 17 weeks and 21 weeks
The The Yesavage Geriatric Depression Scale (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings.
Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from Instrumental Activities of Daily Living performance measured with The Lawton Instrumental Activities of Daily Living (IADL) Scale at 13 weeks , 17 weeks and 21 weeks
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs (See Try this: Katz Index of ADLs). The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale.
Scores range from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Secondary outcomes (4)
Change from the balance and gait performance measured with the Tinetti test at 13 weeks , 17 weeks and 21 weeks
The Tinetti-test, also called Performance-Oriented Mobility Assessment (POMA) assesses a person's perception of balance and stability during activities of daily living and their fear of falling. It is a very good indicator of the fall risk of an individual.
The test comprises two short sections that contain one examining static balance abilities in a chair and then standing, and the other gait It has better test-retest, discriminative and predictive validities concerning fall risk than other tests including Timed Up and Go test (TUG), one-leg stand and functional reach test.
The Tinetti test has a gait score and a balance score. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28. The lower the score on the Tinetti test, the higher the risk of falling.
Tineti tool score: Risk of fall: ≤ 18 High, 19-23 Moderate, ≥ 24 Low
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the upper limb range of movement at 13 weeks , 17 weeks and 21 weeks
The range of movement of the wrist, elbow and shoulder will be measured with the goniometer
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Reaction speed or number of attempts during the sessions at 13 weeks , 17 weeks and 21 weeks
The data related to the reaction speed or number of attempts during the sessions and each game performed will be measured and registered by the technological devices
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Number of correct tries in each game at 13 weeks , 17 weeks and 21 weeks
The data related to the number of correct tries in each game performed will be measured and registered by the technological devices
Measured: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults Institutionalized in Residential HomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pre-test post-test study.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa María Garrido Ardila, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891912
- Sponsor's protocol ID
- 03/2020
- Status last verified
- May 2023
- First submitted
- 15 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Technological Devices in Older Adults
- ClinicalTrials.gov ID
- NCT05891912
- Acronym / sponsor ID
- 03/2020
- Keywords
- older adults,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical trial with users of health care centres and nursing homes in Extremadura (Spain). Inclusion criteria are: women and men over 55 years of age with a Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment) who are able to walk independently. Exclusion criteria are: patients with severe cognitive impairment or language impairment that prevents the use of verbal communication, non-autonomous gait and severe limitation of mobility at the level of the upper limb.
Treatment schedule: 30 min sessions, twice a week during 12 weeks
- 1 session per week: 15min small TABLET and 15min LIGHTS game.
- 1 session per week: 15min TABLE TABLET and 15min game of grape harvesting.
The intervention will be carried out by occupational therapists or physiotherapists.
The intervention period and evaluations will be performed as follows:
- Training of Occupational therapists/physiotherapists: 1 week prior to the start of the intervention for.
- Week 0- Initial measurements
- Week 1-12: device interventions
- Week 13: Final measurements
- Week 17: First follow-up measurement
- Week 21: Second follow-up measurement
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre-test post-test study.
| Arm | Type | Receives |
|---|---|---|
| Technological devices intervention | Experimental | Other: Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)The intervention will be in individual sessions with the following technological devices and games: * Vertical screen: game of lights and vintage game. * Horizontal screen: cognitive function and activities of daily living games * Tablets: cognitive function and activities of daily living games |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women and men over 50 years of age
- Minimental State Examination (MMSE) equal or higher than 21 (no cognitive impairment or mild to moderate cognitive impairment)
- Independent gait
Key exclusion criteria (3 listed)
- patients with severe cognitive impairment or language impairment that prevents the use of verbal communication
- No independent gait
- Severe limitation of upper limb range of movement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function)The treatment will be performed in 30 min sessions, twice a week during 12 weeks. the weekly sessions will include the following games: * 1 session per week: 15min small TABLET and 15min LIGHTS game. * 1 session per week: 15min TABLE TABLET and 15min game of VINTAGE. | Other | Technological devices intervention |
Primary outcome
Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
The Mini-Mental State Examination (MMSE) is a set of 11 questions that doctors and other healthcare professionals commonly use to check for cognitive impairment. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Change from the Activities of daily living performance measured with the Barthel Index at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge. Each item is rated in terms of whether the patient can perform the task independently, with some assistance, or is dependent on help based on observation (0=unable, 1=needs help, 2=independent). The final score is x 5 to get a number on a 100 point score. Proposed guidelines for interpreting Barthel scores are that scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.2 Most studies apply the 60/61 cutting point.
Change from the Depression level measured with the Yesavage Geriatric Depression Scale (GDS) at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
The The Yesavage Geriatric Depression Scale (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. (GDS) is an assessment tool for diagnosing depression in older adults and expresses the degree of satisfaction, quality of life and feelings. Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.
Change from Instrumental Activities of Daily Living performance measured with The Lawton Instrumental Activities of Daily Living (IADL) Scale at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
The Lawton Instrumental Activities of Daily Living Scale (IADL) is an appropriate instrument to assess independent living skills. These skills are considered more complex than the basic activities of daily living as measured by the Katz Index of ADLs (See Try this: Katz Index of ADLs). The instrument is most useful for identifying how a person is functioning at the present time, and to identify improvement or deterioration over time. There are eight domains of function measured with the Lawton IADL scale. Scores range from 0 (low function, dependent) to 8 (high function, independent) for women, and 0 through 5 for men.
4 secondary outcomes
Change from the balance and gait performance measured with the Tinetti test at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the upper limb range of movement at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Reaction speed or number of attempts during the sessions at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Change from the Number of correct tries in each game at 13 weeks , 17 weeks and 21 weeks
Time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Trinidad Rodríguez-Dominguez, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technological devices intervention (use of tablet and big screen with games oriented to training physical and cognitive function) in people with Older Adults Institutionalized in Residential Homes, run by University of Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ELISA MARIA GARRIDO-ARDILA, PhD (0034 927 257450 ext. 21500, egarridoa@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the cognitive impairment measured with the Minimental State Examination at 13 weeks , 17 weeks and 21 weeks (time frame: It will be measured at week 0 (pre-intervention), week 13 (post-intervention), week 17 (follow up)and week 21 (follow up)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.