GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe.

BACKGROUND: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial. METHOD: GOIZ ZAINDU is a 1-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no diagnosis of dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a multidomain intervention (MD-Int) or regular health advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (mild cognitive impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factor control, nutritional counseling, physical activity, and cognitive training. The primary outcomes were retention rate and adherence to the intervention program. Exploratory cognitive outcomes included changes in the Neuropsychological Test Battery z-scores. Analyses were performed according to the intention to treat. RESULTS: One hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The MD-Int (n = 61) and RHA (n = 64) groups were balanced in terms of their demographics and cognition. Fifty-two (85%) participants from the RHA group and 56 (88%) from the MD-Int group completed the study. More than 70% of the participants had high overall adherence to the intervention activities. The risk of cognitive decline was higher in the RHA group than in the MD-Int group in terms of executive function (p =.019) and processing speed scores (p =.026). CONCLUSIONS: The GOIZ-ZAINDU study proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. The exploratory efficacy results showed a lower risk of decline in executive function and processing speed in the intervention group. These results support the design of a large-scale efficacy trial. TRIAL REGISTRATION: GOIZ ZAINDU feasibility trial was approved and registered by the Euskadi Drug Research Ethics Committee (ID: PI2017134) on 23 January 2018. Retrospectively registered in ClinicalTrials.gov (NCT06163716) on 8 December 2023.

Fibromyalgia and nonfibromyalgia chronic pain: Differences in psychological characteristics and treatment outcomes.

The aim of this study was to explore differential psychological profiles among patients with chronic pain with and without fibromyalgia, and to determine the results of the cognitive behavioral therapy (CBT) for pain. Thirty patients with chronic pain and 60 patients with fibromyalgia were referred to 10 weekly sessions of CBT in a general hospital and were evaluated in pain-related variables, psychopathological symptoms, coping strategies, resilience, and quality of life. The program was implemented in specific groups for patients with fibromyalgia and nonfibromyalgia chronic pain. After the intervention, patients with fibromyalgia showed higher levels of psychopathology, rated their health status as poorer, and presented larger amplification of symptoms, higher levels of somatization, a more ruminating style of thinking and greater distress. Patients without fibromyalgia achieved better therapeutic results in both pain intensity (d = 0.39 vs. d = 0.12) and psychopathological distress (d = 0.77 vs. d = 0.11) compared to patients with fibromyalgia. Therefore, differential profiles and limited therapeutic results in fibromyalgia patients suggest the need to outline differentiated treatments and include other therapeutic strategies.

Dynamic evaluation of the comparative effectiveness of an integrated program for heart failure care.

RATIONALE, AIMS AND OBJECTIVES: An integrated care program for heart failure (HF) was developed in the Basque Country in 2013. The objective of this research was to evaluate its effectiveness through the number of hospital admissions in three integrated healthcare organizations (IHOs), taking into account the longitudinal nature of the disease and the intensity of the implementation. METHODS: A retrospective observational study was carried out, based on data entered in administrative and clinical databases between 2014 and 2018 for a total population of 230 000. In addition to conventional statistical analyses, Andersen-Gill models for recurrent events were used, incorporating dynamic variables that allowed assessment of the intervention's intensity before each hospitalization. RESULTS: A total of 6768 patients were analysed. Age (hazard ratio [HR] = 1.016; 95% confidence interval [CI] 1.011-1.022), the Charlson index (HR = 1.067, 95% CI 1.047-1.087), and the number of previous hospitalizations (HR = 1.632, 95% CI 1.557-1.712) were risk factors for readmission. Differences between IHOs were also statistically significant. Greater intervention intensity was associated with a lower hospitalization rate (HR = 0.995, 95% CI 0.990-1.000). As indicated by the interaction between intervention intensity and IHO, differences between IHOs disappeared when intensity rose. No inequities in hospitalization were found as a function of deprivation index or sex. Nonetheless, inequity in the implementation of the program by sex was clear, women with HF receiving less intense intervention than men with the same level of comorbidity and age. CONCLUSIONS: The extent of program implementation measured by intervention intensity is a main driver of the effectiveness of an educational and monitoring program for HF. The evaluation of HF program effectiveness on readmissions must take into account the entire natural history of the disease. Implementation intensity explains differences between IHOs.