CompletedNot Applicable

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

Spain187 participantsStarted 2023-07-01

Plain-language summary

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

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * severe cognitive impairment, situations of great physical dependence that lack help, or psychotropic substance abuse or dependence.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

quality of life

Timeframe: up to 18 months

Cognitive impairment

Timeframe: up to 18 months

depression

Timeframe: up to 18 months

perceived loneliness

Timeframe: up to 18 months

Activities of daily living (ADL)

Timeframe: up to 18 months

Instrumental activities of daily living (iADL)

Timeframe: up to 18 months

Tinetti scale

Timeframe: up to 18 months

Trial details

NCT IDNCT07362381

SponsorUniversidad de Zaragoza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More 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 trials

Plain-language summary

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

quality of life

Timeframe: up to 18 months

Cognitive impairment

Timeframe: up to 18 months

depression

Timeframe: up to 18 months

perceived loneliness

Timeframe: up to 18 months

Activities of daily living (ADL)

Timeframe: up to 18 months

Instrumental activities of daily living (iADL)

Timeframe: up to 18 months

Tinetti scale

Timeframe: up to 18 months