A Randomized Controlled Trial to Address a Multimodal Intervention in the Elderly: the Efficacy of the CAMINN Study
Phase: NA
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
Sponsor: Universidad de Zaragoza

 
 
 
 
Title of the study: A Randomized Controlled Trial to 
Address a Multimodal Intervention in the Elderly 
 
NCT number: Not available yet 
 
Date: 14/01/2026 
 
 
 
 
 
 

Study protocol 
At the beginning of the intervention, an initial evaluation was carried out using the 
different tests for all the participants (baseline). During the intervention, the users 
received weekly sessions (individual and group) via videoconference from a social 
worker, a psychologist, a sociocultural activities technician, and a physiotherapist. 
Appointments were previously arranged according to the availability of each user. 
Participants were classified according to the following therapeutic profiles: active aging, 
emotional disorders, unwanted loneliness, residential care center users, cognitive 
impairment, physical limitations and social exclusion. Table 1 shows a typical schedule 
for one of the participants. Nevertheless, the number of sessions may vary depending on 
the therapeutic profile of the participants. For example, the unwanted loneliness and 
social exclusion profiles have 5 weekly sessions, the physical or cognitive limitation 
profiles have 3 to 3.5 weekly sessions, while the active aging profile has 2 to 2.5 weekly 
sessions. Individual sessions were held on a fortnightly basis.  
 
Table 1. Schedule of a typical weekly intervention for one of the participants. 
Time 
Monday 
Tuesday 
Wednesday 
Thursday 
Friday 
 
12:00-13:00  
Recreational 
group session 
 
Cognitive 
group session 
with 
psychologist 
 
Individual follow-up 
session with social 
worker/ psychologist 
 
17:00-18:00 
 
 
 
Gym group 
session with 
physiotherapist 
 
Approximately halfway through the intervention, the same instruments were applied 
again and right at the end of the intervention, in order to verify our hypothesis. Therefore, 
in addition to the baseline measures, we obtained two more measures (an intermediate 
data collection at the middle of the intervention and another one at the end).  
The following inventories were used as instruments to measure the effectiveness of the 
intervention. To cognitively assess the participants, the MMSE (Folstein et al., 1975) was 
used. The FUMAT scale (Gómez et al., 2008) was used to assess quality of life by means 
of 8 different dimensions. The abbreviated version of the Yesavage Geriatric Depression 
Scale (Martínez de la Iglesia et al., 2002) was used to assess depression. Loneliness was 
assessed using the revised ESTE scale (ESTE-R) (Rubio & Aleixandre, 1999). 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) whereas 
the Lawton and Brody’s test (Lawton & Brody, 1970) was used to measure the ability to 
perform instrumental activities of daily living (IADL). Finally, Tineti’s scale (Tinetti, 
1986) was used to assess the balance and gait of older adults and determine the risk of 
falls. 
 
 
 
 
 

Statistical analysis plan 
Initially, the Kolmogorov-Smirnov test was applied to assess the normality of the 
variables. Only the Fumat test values showed a normal distribution, so parametric 
statistics were used for the analysis of this particular case. The remaining variables 
showed a non-normal distribution, so nonparametric tests were used. Data were reported 
as mean ± SD. The demographic and clinical variables of the groups at baseline were 
compared using the chi-square test for categorical variables and the independent-samples 
t test for quantitative data.  
This research also performed Wilcoxon signed rank tests to examine whether there was a 
statistically significant difference in a group of participants between time intervals (t0: 
baseline, t1:mid intervention, t2: end of intervention). In addition, a 2-way repeated 
measure analysis of Variance (ANOVA) was performed to study the interaction effects 
of time (at baseline, mid intervention and end of intervention) in the two intervention 
groups (experimental and control) in the Fumat scale, together with the plot of the 
estimated marginal means. Partial eta-squared (ηp2) was used to categorize effect sizes 
when the distribution was normal. In this case, ηp2 = 0.01 for a small effect, 0.06 for a 
medium effect, and 0.14 for a large effect, respectively. When the data did not follow a 
normal distribution, Cohen's r ratio (r = Z/sqrt(N)) was used. This ratio indicates that a 
large effect corresponds to r = 0.50, a medium effect to r = 0.30, and a small effect to r = 
0.10, respectively. The size of the effect will indicate us the practical relevance. Version 
26 SPSS software was used to perform all the statistical analyses. The level of 
significance was set at 0.05.