Feasibility of a Multidisciplinary Student-Led Program to Improve Frailty in Nursing Home Residents

NCT07182747 | Not Yet Recruiting

• 1 other identifier: A01037772
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

BACKGROUND Frailty, regarded as a potentially reversible process and defined as a progressive deterioration of physiological systems and intrinsic capacity, constitutes a key risk factor for disability, dependency and institutionalisation. Currently, it is estimated that between 50% and 75% of older adults living in residential care facilities present with frailty. This clinical profile is often directly associated with multiple comorbidities (around 65-85% of this population suffer from several chronic conditions), emotional decline, polypharmacy, malnutrition and a high prevalence of functional and cognitive impairment. Consequently, two out of every three older adults will require long-term care in specialised centres during their lifetime. In this context, nursing homes represent a key setting not only for providing care, but also for the prevention, detection and management of conditions such as frailty. However, care in residential facilities continues to focus on addressing established problems, with low participation in activities with potential benefits and a high perception of loneliness. Therefore, interventions in these contexts aimed at improving frailty are both necessary and urgent, particularly those that integrate a biopsychosocial approach, promote autonomy and foster active ageing. Several studies have demonstrated that multidisciplinary intervention programmes and multicomponent physical training are effective in preventing frailty and its consequences. Nevertheless, their widespread implementation is limited by several factors. On the one hand, there is a lack of scientific evidence on the cost-effectiveness of such interventions, and on the other, healthcare systems face budgetary constraints in a context of increasing demand for geriatric care. In the search for more effective interventions to improve frailty and other related variables in older adults residing in nursing homes, supervised multidisciplinary programmes, delivered by health sciences students and implemented by nursing students, may represent a viable alternative. In this regard, students of Physical Activity and Sport Sciences (CAFYD) possess the knowledge required to design physical activity plans adapted to the capacities and needs of older adults. However, given the nature of their care role, nurses provide added value: their continuous presence in the clinical setting enables them to establish a closer therapeutic bond with the patient, ensure thorough monitoring of their progress, and facilitate coordination between physicians and other healthcare team members. These features make nurses key agents in the implementation of comprehensive, person-centred interventions. Despite the potential of implementing a multidisciplinary intervention programme through health sciences students to improve frailty in older adults living in residential facilities, to the best of our knowledge, no similar interventions exist. Therefore, it is necessary to assess the feasibility of implementing such a proposal prior to conducting a randomised controlled trial to confirm its clinical effectiveness, as this approach plays an important role in determining the most appropriate trial design. To this end, different feasibility study guidelines recommend including variables such as acceptance, adherence and dropout rates as key markers for successful implementation. STUDY'S HYPOTHESIS The main hypothesis of the CUIDAFRAIL project is that a supervised multidisciplinary intervention programme carried out by nursing and Physical Activity and Sport Sciences students is feasible for improving frailty and other related variables in older adults living in residential care facilities. AIM AND OBJECTIVES The aim of the CUIDAFRAIL project is to examine the short- term and medium-term effects of a nursing students' multidisciplinary intervention programme on frailty among older adults living in nursing homes. The secondary objectives of this project are the following:

1. 1.To examine the effects of the intervention on frailty, as well as other frailty-related variables, including physical fitness, functionality, fear of falling, emotional status, loneliness, social support and quality of life in older adults living in residential care facilities.
2. 2.To examine the effects on physiological and clinical parameters associated with frailty.
3. 3.To explore the perceptions and experiences of older adults participating in the programme upon completion.
4. 4.To explore the perceptions and experiences of nursing and Physical Activity and Sport Sciences students upon completion of the programme.

Conditions

Frailty

Keywords

Frailty; older adults; intervention programme; Physical Activity; Activities of Daily Living; Nursing student; feasibility

Outcome Measures

Primary Outcomes (5)

• Adoption

  The proportion of older adults who agree to participate out of the total number of older adults offered the programme. This information will be obtained from the records of eligible individuals and those ultimately included.

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Adherence

  Adherence: The proportion of participants who complete at least 8 of the 12 weeks comprising the entire programme.

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Dropout

  The proportion of participants who withdraw from the intervention out of the total number of individuals who agreed to participate and began the programme.

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Perceived quality of the intervention

  Assessed using the Net Promoter Scale (NPS), a tool used to measure user satisfaction with an intervention through the question: "How likely are you to recommend this to someone in a similar situation?" Scores range from 0 to 10, with scores below 5 indicating dissatisfaction and scores above 5 indicating satisfaction.

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Frailty

  Clinical Frailty Scale (CFS). The CFS is a clinician-administered scale comprising nine levels that classify patients' degree of frailty. Each level describes a set of characteristics related to physical condition, functionality, and cognitive status, ranging from 1 (very fit) to 9 (terminally ill). Scores are assigned based on the patient's overall functioning in daily life, including mobility, dependence for basic and instrumental activities of daily living, presence of chronic diseases, and cognitive impairment. The scale has been validated in residential settings and can also be used in individuals with cognitive impairment, as it does not require self-reporting. Higher scores indicate greater frailty.

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

Secondary Outcomes (29)

• Physical condition (SPPB total score)

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Physical condition (Timed Up and Go test)

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Leg strength

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Grip strength

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

• Fall risk

  [Time Frame: T1=pre-test (immediately before being enrolled onto one of the groups); T2=post-test (between 1-12 days after the visit programme has been completed); T3=6-month follow-up (six months after finishing the intervention programme)]

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants allocated to the 'intervention group' arm will receive the usual care offered by the Public Andalusian Healthcare Service in conjunction with a 12-week nursing students' intervention programme.

Behavioral: Nursing students' intervention programme; Behavioral: Standard care from Public Andalusian Health Service

Control group

ACTIVE COMPARATOR

Participants allocated to the 'control group' arm will only receive the usual care offered by the Public Andalusian Healthcare Service for 12 weeks.

Behavioral: Standard care from Public Andalusian Health Service

Interventions

Nursing students' intervention programme BEHAVIORAL

12-week intervention programme conducted by nursing students and students trained in Sciences of Physical Activity and Sport (CAFYD). Participants will receive weekly three sessions of 45-60 minutes. It will include physical exercise and occupational therapy sessions aimed at improving frailty and other related outcomes in the participating older adults through interdisciplinary collaboration and ongoing monitoring. Nursing students will implement personalised intervention programmes designed by a multidisciplinary team comprising CAFYD students, an occupational therapist, and nurses experienced in the care of older adults.

Intervention group

Standard care from Public Andalusian Health Service BEHAVIORAL

They will receive the standard care provided by the Andalusian Health Service as part of its portfolio of services offered to older adults residing in institutions, as well as the standard care provided by the institutions in which they live. As part of these services, older adults receive support such as accommodation, laundry, health promotion activities, health monitoring, assistance with activities of daily living, individual, group, and community social care, as well as means of communication with the outside world. The action plans or protocols established in care processes for older adults living in nursing homes do not include externally delivered multidisciplinary intervention programmes.

Control group; Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years.
• Living in one of the institutions participating in the study.
• Signing the informed consent to participate in the study.

You may not qualify if:

• Requiring palliative care
• Having moderate or severe cognitive impairment (Pfeiffer Test \>4); hypotension (systolic blood pressure \<90 mmHg, diastolic blood pressure \<60 mmHg), anemia (hemoglobin level \<9 g/dL), any acute metabolic disorder, uncontrolled hypertension (systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg), uncontrolled arrhythmia, stable/unstable angina, uncontrolled chronic or metabolic disease, and advanced cerebrovascular or peripheral vascular disease
• Having undergone surgery within the last six weeks.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Universidad de Almería

Almería, Spain, 04120, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

José Manuel Hernández Padilla, Professor

CONTACT

+34950214588; jhp861@ual.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The type of intervention on which the project is based does not allow for the participants to be masked and they will know to which group they are allocated. However, the team that will collect data (assessors) will not know the group to which each participant is allocated. To ensure assessor masking, participants will be instructed to never reveal the group to which they have been assigned and assessors will be instructed to never ask the participants to which group they have been assigned. The assessors will not participate in the recruitment process, the supervision of nursing students' interventions, nor the data analysis process. The group to which the participants have been allocated will be numerically coded (not labelled) in the database and the researchers in charge of data analysis will not know which numerical code refers to the intervention group and which code refers to the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (Full)

Model Details: Older adults who meet the inclusion criteria and voluntarily accept to participate in this study will be randomly allocated to one of two arms: intervention group (arm 1) or control group (arm 2). Participants from both arms will be assessed at the same time for data collection purposes (pre-test, post-test and 6-month follow-up) and they will be exposed to the experimental condition (intervention group) or the control condition (control group) at the same time for 12-weeks.

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be made available to other researchers once it has been published in a scientific journal (estimated timeframe: starting December 2026) and will be available for 6 months.

Locations

ES (1)