Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT07113860
Eligibility Criteria:
Inclusion criteria are:
* living in the community in Barcelona or nearby areas;
* both partners being aged ≥ 65 years;
* speaking fluent Catalan or Spanish;
* being married, having a partner with whom they co-habit, or having had a partner for at least one year and with whom they meet at least twice a week;
* having access to a smartphone, tablet, laptop, or computer with internet;
* both partners being willing to participate in the study and providing written informed consent.
Although the use of a chronological age cut-off to define older people is inherently arbitrary, this study adopts the threshold of 65 years and older to establish inclusion criteria for participation. This decision reflects the increasing self-relevance of age-stereotypes and self-perceptions of aging in later life, particularly among the oldest age groups. Participants can either possess a device that can be connected to the internet or use the device of a family member, neighbor, or friend. Moreover, participants with low technology literacy can nonetheless take part in the study as during baseline assessment the research team will show them how to complete the online questionnaires. Moreover, the research team will be available via email and phone to answer participants' queries related to completion of the online questionnaires. Both retired and working people are eligible to take part in the study. People of any race can take part in the study. Couples of all sexual orientations are welcome to participate in the study.
Exclusion criteria are:
* having a self-reported or clinically diagnosed neurodegenerative disorder, and/or an Adult Lifestyles and Function Interview Mini Mental State Examination (ALFI-MMSE) score of \< 15 out of 22, indicating mild cognitive impairment or dementia. The research team has considerable experience with the administration of the MMSE and will adjust scores for individuals with low cultural background;
* currently having a clinical diagnosis of mental health disorder that significantly impacts on the daily functioning of the individual (i.e., a diagnosis that significantly impacts the participants ability to work, do house chores, and/or engage socially);
* current substance use disorder (alcohol or drug abuse), or a history of substance abuse within the past five years that may interfere with study participation or adherence to the intervention;
* having a physical condition or physical limitations that impair from starting a physical activity intervention consisting in walking between three to five times per week and to do some physical tasks such as stand up from and sit down on a chair and back scratch;
* severe hearing impairment (deafness).
Physical limitations will be self-reported by participants via phone but also further objectively assessed by the researchers at baseline assessment. Individuals with neurodegenerative disorders will be excluded as it could be difficult for them to understand and participate in the psychoeducational sessions, and/or engage in brisk walking. Individuals with current severe mental health disorders and/or with substance abuse will be excluded as these groups are less likely to be compliant with intervention conditions. However, individuals with more common mental health disorders (i.e., depressive disorders and anxiety disorders) that are not severe enough to significantly impact the daily functioning of the individual will be allowed to take part in the study. Individuals with significant physical limitations will be excluded as they could put themselves at risk of falling while engaging in physical activity/walking.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07113860
Study Brief:
Protocol Section:
NCT07113860