The Effects, Usability, Satisfaction, Barriers, and Benefits of a Remote, Multidomain Website-based Intervention to Prevent Cognitive Decline in Older Adults

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorInstituto Mexicano del Seguro Social

About this trial

Mexico exhibits a high prevalence of dementia, exceeding 8%, and it is estimated that by 2050 around 3.5 million older adults will be living with this condition. In light of this scenario, it becomes a priority to intervene on the factors associated with the development of dementia through preventive strategies, particularly via multicomponent programs that integrate physical activity, cognitive training, and other components aimed at modifying lifestyles, applied early, before the appearance of clinical symptoms.

In order to expand access to this type of intervention for older adults with limited time or resources for face-to-face care, the implementation of preventive programs remotely through the use of digital media has been proposed. Web platforms constitute an accessible and cost-effective alternative for delivering complex interventions, such as the 'Mind and Movement for Cognitive Health (MeMo-Salud-Cog)' program, designed to promote lifestyles conducive to cognitive health and which has shown promising preliminary results in overall cognitive function, memory, executive function, and attention.

However, the use of digital systems by older adults may be limited by barriers associated with ageing (cognitive, sensory, physical, and motivational), as well as social aspects (education and social isolation) or cultural factors (beliefs and perceived usefulness), which can affect the continuity of their participation. In this context, the present proposal suggests adapting the MeMo-Salud-Cog program to a remote modality, through a website and remote monitoring by healthcare professionals, with the aim of evaluating its feasibility based on usability, satisfaction, effect, and adherence, as well as analyzing perceived acceptability, emphasizng the barriers and benefits of remote intervention.

The investigators will employ a mixed design combining quantitative and qualitative methods, with a pre-post evaluation without a control group in the quantitative part and semi-structured interviews in the qualitative part (pilot study). The study population will consist of independent individuals aged 60 to 75 years affiliated with IMSS at the Family Medicine Unit 1 and 28, with or without cognitive complaints, but without impairment (MMSE ≥ 24), functional independence, at least one vascular risk factor, with a mobile phone or computer, and an informed consent letter.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

With and without cognitive complaints (i.e., they have responded 'yes' to the question: 'Do you feel that your memory or learning abilities have worsened recently?").

They demonstrate independence in activities of daily living and instrumental activities of daily living. • With one or more vascular risk factors (for example, type 2 diabetes or hypertension).

With a score on the overall cognitive function test of≥ 24 on the Mini-Mental State Examination.

With a score between 0-4 on the Blessed Dementia Scale.

Disqualifiers

Depression (score > 15 according to the Epidemiological Studies Center Depression Scale - Revised [CESD-R]).

With a clinical diagnosis of any significant neurological or psychiatric disorder (for example, Parkinson's disease, schizophrenia).

With any heart disease.

Presence of a recent cancer diagnosis.

Trial design

Design model

Single group

Treatments tested in this trial

  • Multi-domain intervention: Physical activity, cognitive training, and educational program through a website

    Other intervention

    MeMo- Health- Cog Remote is a Multidomain intervention lasting 60 minutes, comprising 30 minutes of aerobic exercise, 20 minutes of cognitive training, and 5 minutes each for warm-up and cool-down. It is delivered at least three times weekly for 12 weeks. The weekly educational topic can also be reviewed on the same page, covering subjects such as active aging, healthy eating, and socialization. Participants access the program through a website, with options to watch the videos on TV.

Treatment groups

71 Participants
are divided into 1 treatment group
Group A: MeMo-Health-Cog- remoteOther 1 intervention

Trial outcomes

Primary outcomes

1

Subjective cognitive enhancing.

Through a questionnaire, the subjective memory complaint will be assessed by responding positively (≥1) or negatively (≤0) to questions such as: Do you feel you have trouble remembering things? Do you forget conversations? Do you repeat the same questions several times? Have you recently forgotten to turn off the stove? Do you think you have memory problems?

Time frame
Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.
2

Cognitive enhancers-global-MoCA

The assessment will be conducted using: a) The Montreal Cognitive Assessment (MoCA), which scores from 0 to 30 points.

Time frame
Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.
3

Cognitive enhancers-psycological (executive function and mental flexibility)

Executive function and mental flexibility will be assessed using the Trail Making Tests, Part A and Part B (TMT-A and TMT-B). The results of these tests are expressed as the time, in seconds, each task takes to complete. Processing speed, measured with the Digit Symbol Substitution Test (DSST), will be determined by the total number of correct matches of numbers and symbols achieved in 90 seconds.

Time frame
Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.
4

Cognitive enhancers-global-Blessed

The Blessed Dementia Scale (Spanish version), comprising three sections: i) changes in daily activities (8 questions), ii) changes in habits (3 questions), and iii) changes in personality, interests, and impulses (11 questions), with a total score ranging from 0 to 28.

Time frame
Measurements will be taken on Day 0 and Month 3. The difference between these two will be calculated.

Secondary outcomes

1

Digital usability

The measure of how efficiently, easily, and satisfactorily users can accomplish their goals on a website is assessed using the Spanish version of the usability questionnaire for interactive applications (Mx-MAUQ, in English). It consists of 21 items rated on a 7-point Likert scale (from strongly disagree to strongly agree), divided into three areas: (1) ease of use and satisfaction (8 items); (2) system information arrangement (6 items); and (3) usefulness (7 items). The overall score is calculated by summing all item scores and dividing by the total number of items (11).

Time frame
Measurements will be collected at 1 and 3 months, and the difference between the two assessments will be calculated.

Other outcomes

1

Perception of the risk and severity of memory decline or loss.

Semi-structured qualitative questions (Health Belief Model): What does the reduction or permanent loss of memory imply or mean to you? and Do you know anyone who has lost their memory? How would you rate this situation and why?

Time frame
Up to 12 weeks
2

Perception of barriers to intervention.

Semi-structured qualitative questions (Health Belief Model): What have been the barriers that have made it difficult for you to participate in the program and maintain commitment to the recommended activities?

Time frame
Up to 12 weeks.
3

Perception of benefits and suggestions to intervention.

Semi-structured qualitative questions (Health Belief Model): What did you like about this program? Why? Were the information and materials shared with you to your satisfaction? Why or why not? Would you recommend this program to your friends? And why? What did you expect when joining this program? Has participation in the program met your expectations? Why or why not? What changes do you consider appropriate to make this program, delivered through a website, more widely used and beneficial for older adults like you and those of even greater age?

Time frame
Up to 12 weeks.

Sponsors and contacts

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