Frailty Musculoskeletal Diseases
Conditions
Interventions
The clinical trial will have two study arms: an experimental group receiving a multicomponent intervention and a control group receiving usual care and follow-up at a primary health care centre.
The r
Sponsors
AP-OSIs Gipuzkoa
Hospital Costa del Sol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged over 70 years, presenting frailty (SPPB 90 points), resident in the autonomous community in question and agree to participate.
Exclusion criteria
Exclusion criteria: 1. Subjects who are terminally ill (as defined in the guidelines published by the Spanish Society of Palliative Care) 2. Subjects who do not habitually reside in the study area (i.e. those who reside for more than six months per year elsewhere) 3. Those who have difficulty in communication in Spanish or Basque (the latter language, for subjects resident in Gipuzkoa)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At baseline and twelve months’ follow-up: 1. Functional capacity measured by the stand up and walk test. A cut-off point of 12 seconds will be applied to identify subjects with low functional capacity. 2. The incidence of adverse events, a score less than or equal to 90 points in the Barthel test will be considered to represent dependency. Other adverse events assessed during the follow-up year will be institutionalisation and hospitalisations (by number, hospital service required, type – programmed or urgent – and duration). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of transitions from frailty to robustness, at six and twelve months. Patients will be classed as robust if they obtain a score greater than or equal to 10 in the SPPB test 2. Incidence of dependency at six and twelve months 3. Incidence of institutionalisation at six and twelve months 4. New hospitalisations at six and twelve months 5. Level of physical activity at six and twelve months. This parameter will be evaluated using a scale adapted from the WHO recommendations on physical activity for elderly people 6. Prevalence of polypharmacy and potentially inadequate prescriptions at six and twelve months. The number of STOPP criteria met will be determined, for the three time points (baseline and at six and twelve months of follow-up) 7. Prevalence of nutritional alterations at six and twelve months. Alteration is defined as a nutritional score of 17-23.5 points, and malnutrition as a score lower than 17 points in the Mini Nutritional Assessment (MNA) 8. Health-related quality of life at six and twelve months evaluated using EuroQuol 5D 5L. 9. Depression at six and twelve months 10. Validate the expression of the molecular pattern associated with frailty after the proposed intervention and determine the complete transcriptome of each participant 11. Evaluate the efficiency of the intervention (cost-effectiveness) 12. Evaluate the feasibility and adequacy of the intervention (exploration of barriers and facilitators, using a qualitative approach) | — |
Countries
Spain
Contacts
Public ContactItziar;Francisco Vergara Mitxeltorena;Rivas Ruiz
;
Outcome results
None listed