the DEMA-Pro intervention for Cognitive Decline

Phase-Based Estimates
1
Effectiveness
1
Safety
Kindred at Home, Indianapolis, IN
Cognitive Decline+1 More
the DEMA-Pro intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Cognitive Decline

Study Summary

This study is evaluating whether a set of activities can improve sleep habits in people with dementia.

See full description

Eligible Conditions

  • Cognitive Decline
  • Cognitive Dysfunction
  • Subjective Cognitive Decline (SCD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether the DEMA-Pro intervention will improve 1 primary outcome, 5 secondary outcomes, and 1 other outcome in patients with Cognitive Decline. Measurement will happen over the course of immediately after the DEMA-Pro training intervention.

Week 1
Depression
Sense of Well-Being
Baseline to 6 weeks
Physical Function
One year after completing the intervention
Hospitalization Rate
Number, Types of ER visits
Nursing Home Transfers
immediately after the DEMA-Pro training intervention
Staff Experiences of DEMA-Pro training and delivery

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
DEMA-Pro

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. The DEMA-Pro 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.

DEMA-Pro
Behavioral
The DEMA-Pro intervention will be administrated. Subjects will attend six weekly, 1-hour telephone sessions.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 week before dema-pro intervention and post-dema-pro program within 10 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 1 week before dema-pro intervention and post-dema-pro program within 10 days for reporting.

Who is running the study

Principal Investigator
Y. L.
Prof. Yvonne Lu, Associate Professor
Indiana University

Closest Location

Kindred at Home - Indianapolis, IN

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1) Home health service patients aged > 60 years with SCD, with an OASIS- Cognition Function Subscale Score of 1 or 2 (0 = alert/oriented, able to focus and shift attention, comprehends and recalls task directions independently; 1 = Requires prompting [cuing, repetition, reminders) only under stressful or unfamiliar conditions; 2 = Requires assistance and some direction in specific situations [for example, on all tasks involving shifting of attention] or consistently requires low stimulus environment due to distractibility; 3 = Requires considerable assistance in routine situations. Is not alert and oriented or is unable to shift attention and recall directions more than half the time; 4 = Totally dependent due to disturbances such as constant disorientation, coma, persistent vegetative state, or delirium.
Criteria for home health services sites are: 1) a minimum of 300 or more new patients/per site annually; 2) at least 50% w/ length of service > 60 days; 3) staff-to-patient ratio complies with Home Health Agency requirements; 4) no severe state issues. Prior to randomization, sites meeting these criteria will be determined in consultation with the KAH, Clinical Operations Coordinator.

Patient Q&A Section

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

What causes cognitive decline?

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The study reported a higher risk of dementia in later life. Reduced brain volume and subtle neuro-pathological changes including amyloid abnormalities may contribute to brain damage and accelerate its cognitive decline in older people. The study reported a greater risk of AD in later life.

Unverified Answer

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

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Approximately 8% of US adults age 65+ are currently in the process of or have suffered a cognitive decline. Every year nearly 20% of US adults experience a cognitive decline, but the true rate may be up to double that.

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What is cognitive decline?

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The authors describe three modes of decline in cognitive ability (memory, language, and executive functioning) based on a study of 8,541 older Korean-American population. Findings from a recent study suggest that, compared with younger adults, older adults show sharper declines in executive performance and poorer learning of novel tasks. Findings from a recent study may help elucidate the role of different biological and psychosocial risk factors in the development of cognitive impairment and may inform policy development regarding appropriate care and health educational goals in the elderly population.

Unverified Answer

What are the signs of cognitive decline?

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An inability to comprehend the world around us, the inability to pay attention or concentrate, difficulty remembering words, difficulty in making connections and being able to think out complicated things can all be signs of cognitive decline. Being forgetful can be a sign of a long-standing illness, as a result of medical treatment. Memory problems can be caused by Alzheimer's or other diseases.\n

Unverified Answer

Can cognitive decline be cured?

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Cognitive decline is a progressive and disabling illness that cannot be cured but can be controlled with effective interventions, including medications and cognitive activities, such as exercise and education.

Unverified Answer

What are common treatments for cognitive decline?

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The majority of patients presenting to primary care with cognitive decline and MCI report a history of prior cognitive impairment. Those who do not have previous cognitive impairment are commonly treated with memantine, but many are not adequately satisfied with the results of this treatment. It is unclear how many are treated with cholinesterase inhibitors, but in this study, more than half of patients treated with memantine were given cholinesterase inhibitor therapies. It is unclear why antidepressant medications are often prescribed, in part due to concerns over patient safety with antidepressants.

Unverified Answer

What are the common side effects of the dema-pro intervention?

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Although common side effects were rare and mild, people were more likely to drop one of their goals post-intervention depending on the individual's goals. Future studies should determine how people can modify their goals before and after an intervention to reduce such drop-offs and thus, improve the efficacy of the intervention.

Unverified Answer

Does the dema-pro intervention improve quality of life for those with cognitive decline?

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Participants had a high level of baseline QOL compared with a cohort of matched controls. Quality improvement at 12 months after the program was not significantly greater than controls for any domain of QOL. The dema-pro intervention may not improve a person's quality of life. [WithPower, http://www.withpower.com/clinical-trials/complementary-and-alternative-medicine/demed-pro].

Unverified Answer

What does the dema-pro intervention usually treat?

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Most of the interventions have shown to be efficient, but the most effective intervention should be defined for people having their first intervention. Further studies are needed to develop strategies for the early intervention of frail elderly in an urban dema setting.

Unverified Answer

Is the dema-pro intervention typically used in combination with any other treatments?

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There was no evidence of added benefit from the dema-pro intervention alone for symptomatic treatment of the cognitive decline seen in patients who had been on a combination regimen of dema-pro therapy and other standard care therapy.

Unverified Answer

What is the primary cause of cognitive decline?

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The primary cause of cognitive decline in Alzheimer's disease remains a mystery. Aging is believed to be a risk factor for cognitive decline. It is not known why people who live in the community have slower rates of cognitive decline, but those who live alone have more rapid cognitive decline. Smoking, however, is the only significant predictor of a slower cognitive decline rate in those who survive long, and the relationship between smoking and slower cognitive decline is very strong.

Unverified Answer

What is the dema-pro intervention?

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The dema-pro is a combination treatment of four essential components and has positive effects on cognitive abilities, depressive symptoms and social cognition in Alzheimer's disease. dema-pro is now licensed under European law. The dema-pro is a feasible intervention of AD in daily practice in the Netherlands and it is licensed by the Ministry of Health for AD and Dementia in the Netherlands.

Unverified Answer
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