People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive DependencyCAMINNNCT07362381

A Randomized Controlled Trial to Address a Multimodal Intervention in the Elderly

A study testing Multimodal intervention in the elderly in people with People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive Dependency, run by Universidad de Zaragoza at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for: People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive Dependency
What is being tested?: Multimodal intervention in the elderly
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 187 participants
Where: 1 siteSpain
Study dates: 1 Jul 2023to 31 Dec 2024
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 55 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

be over 60 years of age or over 55 years of age with a diagnosed pathology and preferably with a recognized physical and/or cognitive dependency; have the cognitive capacity to maintain fluid conversations and repeat movements through a video call with a professional; be able to acquire the ability to connect autonomously to sessions or have a reference person in charge of the connections; the person must have a television with an HDMI input port.

Who cannot join

severe cognitive impairment, situations of great physical dependence that lack help, or psychotropic substance abuse or dependence.

Trial locations and contacts

1 site in 1 country.

Spain1 site

University of Zaragoza
Teruel, Teruel, 44003

Other trials in Spain

About this study

Official title: A Randomized Controlled Trial to Address a Multimodal Intervention in the Elderly: the Efficacy of the CAMINN Study

The study is a quantitative randomized control trial (RCT) with a longitudinal pre-test, mid-test and post-test within and between subject design. It was conducted between July 2023 and December 2024. This study has been developed under a multicenter basis, since the intervention has involved institutionalized participants in two different nursing homes/care facilities as well as participants in community-dwelling settings. Participants were randomly allocated to two groups (experimental and control). Randomization was performed by means of a computer-generated random number schedule. The trial began with 187 participants. The objective of the intervention was to determine if after the application of a multimodal intervention for 18 months, the subjects would obtain significant improvements in the scores of different clinically validated tests

Conditions: People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive Dependency
Being tested: Multimodal intervention in the elderly

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multimodal intervention in the elderlyOther
To measure the effectiveness of the intervention, eight variables were assessed: cognitive impairment, quality of life, depression, perceived loneliness, functional capacity to perform basic activities and tasks of daily living (ADL), ability to perform instrumental activities of daily living (iADL) and balance and gait. The following inventories were used as instruments to measure the aforementioned variables at baseline, mid intervention and after intervention: MMSE scale, FUMAT scale, the abbreviated version of the Yesavage Geriatric Depression Scale, the revised ESTE scale, the Barthel's scale, the Lawton and Brody's test and the Tineti's scale.

Study groups in NCT07362381
Study group	Role	What they receive
Experimental group	Experimental	Experimental group receives treatment Receives: Other: Multimodal intervention in the elderly
Control	No intervention	Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

quality of life
The FUMAT scale (Gómez et al., 2008) was used to assess quality of life by means of 8 different dimensions. The higher the score across its eight dimensions, the greater the individual's perceived and objective quality of life. It assesses areas such as emotional well-being, relationships, material well-being, personal well-being, physical well-being, self-determination, inclusion, and rights.
Gómez, L. E., M. A., V., Arias, B., \& Navas, P. (2008). Evaluación de la calidad de vida en personas mayores y con discapacidad: La Escala Fumat. Intervención Psicosocial, 17(2). https://doi.org/10.4321/S1132-05592008000200007
Measured: up to 18 months
Cognitive impairment
Cognitive impairment was assessed via the Mini Mental State Examination, MMSE) (Folstein et al., 1975). The MMSE (Mini-Mental State Examination) is a 5-10 minute screening test that assesses cognitive status (orientation, memory, attention, language) through 30 simple questions and tasks. It is scored out of 30, where 24 points suggest cognitive impairment. A higher score indicates better cognitive function.
Folstein, M. F., Folstein, S. E., \& McHugh, P. R. (1975). "Mini-mental state." Journal of Psychiatric Research, 12(3), 189-198. https://doi.org/10.1016/0022-3956(75)90026-6
Measured: up to 18 months
depression
The abbreviated version of the Yesavage Geriatric Depression Scale (Martínez de la Iglesia et al., 2002) was used to assess depression.
The 15-item Abbreviated Geriatric Depression Scale (GDS-15), validated in Spanish by Martínez de la Iglesia et al. (2002), is a reliable, Yes/No questionnaire used to screen for depression in adults over 65. It offers similar diagnostic accuracy to the original 30-item version, typically using a cutoff score >= 5 to indicate depression
Measured: up to 18 months
perceived loneliness
Loneliness was assessed using the revised ESTE scale (ESTE-R) (Rubio \& Aleixandre, 1999). The ESTE scale is a psychometric tool designed to measure unwanted loneliness in older adults, assessing three key factors: social support, use of new technologies, and social participation. It uses a questionnaire that scores from 0 to 30, determining low, medium, or high levels of loneliness. The higher the total score, the greater the level of loneliness reported by the individual.
Rubio, R., \& Aleixandre, M. (1999). La escala "Este", un indicador objetivo de soledad en la tercera edad. Geriatrika. Revista Iberoamericana de Geriatría y Gerontología, 15, 26-35.
Measured: up to 18 months
Activities of daily living (ADL)
The Barthel's scale (F.I. Mahoney \& Barthel, 1965) was used to measure the subjects' functional capacity to perform basic activities and tasks of daily living (ADL).The Barthel's scale is a functional assessment tool that measures a person's independence in 10 basic activities of daily living (ADLs) using a score from 0 to 100. It is based on observation or questioning about the ability to eat, bathe, dress, control bowel and bladder control, transfer, and ambulate. A higher score on the scale indicates a greater level of independence.
F.I. Mahoney, \& Barthel, D. W. (1965). Functional Evaluation: The Barthel Index. Md State Med J., 14, 61-65.
Measured: up to 18 months
Instrumental activities of daily living (iADL)
Lawton and Brody's test (Lawton \& Brody, 1970) was used to measure the ability to perform instrumental activities of daily living (IADL). The Lawton and Brody Scale is a geriatric tool that measures the independence of older adults in performing Instrumental Activities of Daily Living (IADLs). It assesses eight key areas, such as using the telephone, shopping, preparing food, household chores, laundry, transportation, medication management, and finances. Scores are assigned from 0 (dependent) to 1 (independent) per item, for a total of 0 to 8, indicating the degree of autonomy and allowing for early detection of functional decline. Higher scores on the scale indicate greater independence.
Lawton, M. P., \& Brody, E. M. (1970). Assessment of older people: Self-maintaining and instrumental activities of daily living. Nursing Research, 13(3), 278.
Measured: up to 18 months
Tinetti scale
Tineti's scale (Tinetti, 1986) was used to assess the balance and gait of older adults and determine the risk of falls. The Tinetti scale is a geriatric assessment tool that measures the risk of falls in older adults by analyzing their balance and gait through direct observation. It scores everyday tasks (sitting, standing, turning, walking) on a scale of 0 to 28, where less than 19 points indicates high risk and more than 25 indicates low risk.
Tinetti, M. E. (1986). Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc., 34, 119-126.
Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202331 Dec 2024

First posted23 Jan 2026
Study start1 Jul 2023
Primary completion31 Dec 2024
Study completion31 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive DependencyStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 187 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07362381
Sponsor's protocol ID: Protocol 3243/2023
Acronym: CAMINN
Status last verified: Jan 2026
First submitted: 5 Jan 2026
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Palacios-Navarro G, Ramos P, Del Rio D, Gascon-Santos S. A randomized controlled trial to address a multimodal intervention in the elderly: the effects of the CAMINN study. Aging Clin Exp Res. 2026 Mar 25;38(1):125. doi: 10.1007/s40520-026-03371-x.
PubMed 41879890

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial to Address a Multimodal Intervention in the Elderly: the Efficacy of the CAMINN Study
ClinicalTrials.gov ID: NCT07362381
Acronym / sponsor ID: CAMINN / Protocol 3243/2023
Conditions: People 60 Years of Age or Over 55 Years of Age With a Diagnosed Pathology and Preferably With a Recognized Physical and/or Cognitive Dependency
Study type: Interventional
Recruitment status: Completed
Enrolment: 187 participants (actual)
Lead sponsor: Universidad de ZaragozaUniversity, hospital or other
Collaborators: Ingesan-OHLA
Study start: 1 Jul 2023 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 31 Dec 2024 (actual)
First posted: 23 Jan 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental group	Experimental	Other: Multimodal intervention in the elderlyExperimental group receives treatment
Control	No intervention	–Control group

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

be over 60 years of age or over 55 years of age with a diagnosed pathology and preferably with a recognized physical and/or cognitive dependency; have the cognitive capacity to maintain fluid conversations and repeat movements through a video call with a professional; be able to acquire the ability to connect autonomously to sessions or have a reference person in charge of the connections; the person must have a television with an HDMI input port.

Key exclusion criteria (1 listed)

severe cognitive impairment, situations of great physical dependence that lack help, or psychotropic substance abuse or dependence.

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
Multimodal intervention in the elderlyTo measure the effectiveness of the intervention, eight variables were assessed: cognitive impairment, quality of life, depression, perceived loneliness, functional capacity to perform basic activities and tasks of daily living (ADL), ability to perform instrumental activities of daily living (iADL) and balance and gait. The following inventories were used as instruments to measure the aforementioned variables at baseline, mid intervention and after intervention: MMSE scale, FUMAT scale, the abbreviated version of the Yesavage Geriatric Depression Scale, the revised ESTE scale, the Barthel's scale, the Lawton and Brody's test and the Tineti's scale.	Other	Experimental group

Primary outcome

quality of life
Time frame: up to 18 months
The FUMAT scale (Gómez et al., 2008) was used to assess quality of life by means of 8 different dimensions. The higher the score across its eight dimensions, the greater the individual's perceived and objective quality of life. It assesses areas such as emotional well-being, relationships, material well-being, personal well-being, physical well-being, self-determination, inclusion, and rights. Gómez, L. E., M. A., V., Arias, B., \& Navas, P. (2008). Evaluación de la calidad de vida en personas mayores y con discapacidad: La Escala Fumat. Intervención Psicosocial, 17(2). https://doi.org/10.4321/S1132-05592008000200007
Cognitive impairment
Time frame: up to 18 months
Cognitive impairment was assessed via the Mini Mental State Examination, MMSE) (Folstein et al., 1975). The MMSE (Mini-Mental State Examination) is a 5-10 minute screening test that assesses cognitive status (orientation, memory, attention, language) through 30 simple questions and tasks. It is scored out of 30, where 24 points suggest cognitive impairment. A higher score indicates better cognitive function. Folstein, M. F., Folstein, S. E., \& McHugh, P. R. (1975). "Mini-mental state." Journal of Psychiatric Research, 12(3), 189-198. https://doi.org/10.1016/0022-3956(75)90026-6
depression
Time frame: up to 18 months
The abbreviated version of the Yesavage Geriatric Depression Scale (Martínez de la Iglesia et al., 2002) was used to assess depression. The 15-item Abbreviated Geriatric Depression Scale (GDS-15), validated in Spanish by Martínez de la Iglesia et al. (2002), is a reliable, Yes/No questionnaire used to screen for depression in adults over 65. It offers similar diagnostic accuracy to the original 30-item version, typically using a cutoff score >= 5 to indicate depression
perceived loneliness
Time frame: up to 18 months
Loneliness was assessed using the revised ESTE scale (ESTE-R) (Rubio \& Aleixandre, 1999). The ESTE scale is a psychometric tool designed to measure unwanted loneliness in older adults, assessing three key factors: social support, use of new technologies, and social participation. It uses a questionnaire that scores from 0 to 30, determining low, medium, or high levels of loneliness. The higher the total score, the greater the level of loneliness reported by the individual. Rubio, R., \& Aleixandre, M. (1999). La escala "Este", un indicador objetivo de soledad en la tercera edad. Geriatrika. Revista Iberoamericana de Geriatría y Gerontología, 15, 26-35.
Activities of daily living (ADL)
Time frame: up to 18 months
The Barthel's scale (F.I. Mahoney \& Barthel, 1965) was used to measure the subjects' functional capacity to perform basic activities and tasks of daily living (ADL).The Barthel's scale is a functional assessment tool that measures a person's independence in 10 basic activities of daily living (ADLs) using a score from 0 to 100. It is based on observation or questioning about the ability to eat, bathe, dress, control bowel and bladder control, transfer, and ambulate. A higher score on the scale indicates a greater level of independence. F.I. Mahoney, \& Barthel, D. W. (1965). Functional Evaluation: The Barthel Index. Md State Med J., 14, 61-65.
Instrumental activities of daily living (iADL)
Time frame: up to 18 months
Lawton and Brody's test (Lawton \& Brody, 1970) was used to measure the ability to perform instrumental activities of daily living (IADL). The Lawton and Brody Scale is a geriatric tool that measures the independence of older adults in performing Instrumental Activities of Daily Living (IADLs). It assesses eight key areas, such as using the telephone, shopping, preparing food, household chores, laundry, transportation, medication management, and finances. Scores are assigned from 0 (dependent) to 1 (independent) per item, for a total of 0 to 8, indicating the degree of autonomy and allowing for early detection of functional decline. Higher scores on the scale indicate greater independence. Lawton, M. P., \& Brody, E. M. (1970). Assessment of older people: Self-maintaining and instrumental activities of daily living. Nursing Research, 13(3), 278.
Tinetti scale
Time frame: up to 18 months
Tineti's scale (Tinetti, 1986) was used to assess the balance and gait of older adults and determine the risk of falls. The Tinetti scale is a geriatric assessment tool that measures the risk of falls in older adults by analyzing their balance and gait through direct observation. It scores everyday tasks (sitting, standing, turning, walking) on a scale of 0 to 28, where less than 19 points indicates high risk and more than 25 indicates low risk. Tinetti, M. E. (1986). Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc., 34, 119-126.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Derived from this study: PubMed 41879890Palacios-Navarro G, Ramos P, Del Rio D, Gascon-Santos S. A randomized controlled trial to address a multimodal intervention in the elderly: the effects of the CAMINN study. Aging Clin Exp Res. 2026 Mar 25;38(1):125. doi: 10.1007/s40520-026-03371-x.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quality of life (time frame: up to 18 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07362381, which also lists 1 linked publication.

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 23 Jan 2026.