Tiempo Juntos Intervention for Cognitive Decline

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Pennsylvania School of Nursing, Philadelphia, PA
Cognitive Decline+1 More
Tiempo Juntos Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a multilevel intervention can improve sleep and cognitive function in older Latinos.

See full description

Eligible Conditions

  • Cognitive Decline
  • Mild Cognitive Impairment (MCI)

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Tiempo Juntos Intervention will improve 9 primary outcomes in patients with Cognitive Decline. Measurement will happen over the course of 12 weeks.

12 weeks
Change from Baseline Physical Activity Duration at 3 months
Change from Baseline Physical Activity Frequency at 3 months
Change from Baseline Physical Activity Intensity at 3 months
24 weeks
Change from Baseline Physical Activity Duration at 6 months
Change from Baseline Physical Activity Frequency at 6 months
Change from Baseline Physical Activity Intensity at 6 months
48 weeks
Change from Baseline Physical Activity Duration at 12 months
Change from Baseline Physical Activity Frequency at 12 months
Change from Baseline Physical Activity Intensity at 12 months

Trial Safety

Trial Design

2 Treatment Groups

Attention Control
1 of 2
Tiempo Juntos Intervention
1 of 2
Active Control
Experimental Treatment

This trial requires 216 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tiempo Juntos Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Tiempo Juntos Intervention
Behavioral
If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. They will take place at community partner sites during times when all participants can attend. In case of adverse weather, indoor locations are available through community partners. Walks will reflect participant goals and abilities, initially lasting 10 minutes, with 5-minute stretching "warm-up" and 5-minute "cool down" exercises, for a total of 20 minutes. Walk duration will increase by 5 minutes/week to at least 30 minutes with program content delivery time decreasing to accommodate increased walk times within the 1-hour session. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational "booster" sessions delivered every other week via phone calls/text messaging.
Attention ControlIf assigned to this group, participants will take part in 1-hour group (5-6 participants) sessions delivered twice a week for 3 months. The sessions will be with a trained Community Health Worker or qualified staff that will involve reviewing education topics in Spanish related to adult health. They will take place at community partner sites or remotely during times when all participants can attend. In case of adverse weather, indoor locations, or remote options will be available. Upon completing the 3 months of education sessions, for the next 3 months, they will receive educational "booster" sessions delivered every other week via phone calls/text messaging.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 48 weeks for reporting.

Who is running the study

Principal Investigator
G. A. P.
Gloria Adriana Perez, Principal Investigator
University of Pennsylvania

Closest Location

University of Pennsylvania School of Nursing - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Saying that you are willing to attend intervention / education sessions means that you are ready and willing to learn more about the disease of addiction and how to bestsupport your loved one who is struggling. show original
The Montreal Cognitive Assessment (MoCA) score is a measure of cognitive function show original
Can provide informed consent
55+ years
There are many ways to self-identify as Hispanic or Latino show original
In the United States, Spanish is the primary language for more than 50 million people show original
Access to phone/cell
Someone who does less than 150 minutes of activity per week is considered sedentary. show original

Patient Q&A Section

How many people get cognitive decline a year in the United States?

"A relatively high proportion of older adults with normal cognition, defined as having a Mini-Mental State Examination (MMSE) score greater than or = 22, may be at risk for developing clinically meaningful cognitive decline in the 1 year later. Identifying older adults with normal cognition who are at risk for developing clinically meaningful cognitive decline is important because they may benefit from early interventions aimed at slowing cognitive decline, such as dementia prevention programs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cognitive decline?

"Given how prevalent the illness-related problems are, what are common treatments for Alzheimer's disease, aphasia, etc. are: • medication with cholinesterase inhibitors such asdonepezil, eszopiclone, and trazodone;\n• cognitive behavioural therapy and\n• psychosocial intervention such as support groups, respite care and\n• education and counseling;\n• other medications such as acetylcholinesterase inhibitors and memantine;\n• occupational therapy;\n• physical therapies such as reflexology, hydrotherapy and\npulmonary rehabilitation and home-based therapy; and\n• speech therapy." - Anonymous Online Contributor

Unverified Answer

What causes cognitive decline?

"While some factors influence the risk of dementia, their relative importance is not well established. Depressive symptoms, in particular, are an important risk factor for dementia." - Anonymous Online Contributor

Unverified Answer

What is cognitive decline?

"Approximately 10% of respondents met the criteria of cognitive impairment, with a slightly higher prevalence of MCI. Age was positively associated with MCI and negatively associated with cognitive function that did not seem to be mediated by the presence of cognitive dysfunction." - Anonymous Online Contributor

Unverified Answer

Can cognitive decline be cured?

"Cognitive decline cannot be prevented, but can often be delayed. Cognitive reserve helps preserve and stabilize cognitive performance in aging individuals. Improving cognitive reserve may be a successful avenue to treating cognitive decline." - Anonymous Online Contributor

Unverified Answer

What are the signs of cognitive decline?

"The main signs of cognitive decline include (1) difficulty with memory, attention, and orientation, (2) increased confusion and lack of awareness, and (3) difficulty talking in a clear and coherent fashion. Older persons and those with a greater degree of cognitive decline are also at risk of developing some types of dementia and Alzheimer's disease." - Anonymous Online Contributor

Unverified Answer

How serious can cognitive decline be?

"Decline in [some] intellectual capabilities [should be treated as] a major criterion for dementia diagnosis. The diagnosis of dementia due to a decline in intellectual capability is a [severely] disabling illness and should be considered a legitimate medical priority." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cognitive decline?

"Older adults, caregivers, and healthcare providers should be aware that participation in a clinical trial for cognitive decline may not improve quality of life or reduce disability in older adults." - Anonymous Online Contributor

Unverified Answer

What does tiempo juntos intervention usually treat?

"Data from a recent study demonstrated the effectiveness of the TI program among older adults living in the community. Data from a recent study support and extend the findings from previous studies showing that, contrary to claims commonly made about the TI program, the intervention is associated with improvements in multiple areas such as a reduction of falls, mobility and self-care performance, and a decrease in depressive and anxious symptoms; without any evidence of adverse reactions, and, in fact, with a slight reduction in depressive and anxiety symptoms." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of cognitive decline?

"In this cohort, age and pre-existing psychiatric, physiological, or cognitive disorders were the strongest contributors to the observed increase in cognitive decline in subjects with and without CAD. Cognitive decline is more likely to occur with CAD than without CAD." - Anonymous Online Contributor

Unverified Answer

Has tiempo juntos intervention proven to be more effective than a placebo?

"Tiempo juntos could be more effective than a placebo for improving the memory and attention in elders with dementia. Also, the intervention did not affect the memory nor attention of the elders with normal cognitive function." - Anonymous Online Contributor

Unverified Answer

How does tiempo juntos intervention work?

"Participation in the study led to a significant decrease in the performance of short-term memory problems, which were related to the degree to which the intervention was practiced by older people with cognitive impairment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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