Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm for Cognitive Decline

Phase-Based Estimates
2
Effectiveness
3
Safety
Tulane University, New Orleans, LA
Cognitive Decline+2 More
Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Cognitive Decline

Study Summary

This study is evaluating whether a multifaceted strategy for implementing an intensive blood pressure intervention protocol targeting systolic BP <120 mmHg on cognitive decline in racial minority and low-income

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Eligible Conditions

  • Cognitive Decline
  • Cognitive Dysfunction
  • Hypertension

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm will improve 1 primary outcome, 5 secondary outcomes, and 3 other outcomes in patients with Cognitive Decline. Measurement will happen over the course of Baseline to an average of 42 months.

Month 42
Difference in proportion of patients with adjudicated mild cognitive impairment (MCI) or probable dementia (exploratory outcome)
Health-related Quality of Life (HRQoL)
Net difference in mean change in MoCA score
Net difference in mean change in cognitive decline
Net difference in mean change in diastolic blood pressure
Net difference in mean change in executive function
Net difference in mean change in memory function
Net difference in mean change in systolic blood pressure
Side effects

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Intervention

This trial requires 920 total participants across 2 different treatment groups

This trial involves 2 different treatments. Stepped-care Protocol Adapted From The SPRINT Intensive-treatment Algorithm is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Intervention
Behavioral
The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to an average of 42 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to an average of 42 months for reporting.

Who is running the study

Principal Investigator
K. T. M.
Prof. Katherine T Mills, Assistant Professor
Tulane University

Closest Location

Tulane University - New Orleans, LA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
may lead to uncontrolled hypertension show original
Each clinic maintains its own list of providers and nurses/pharmacists. show original
Focusing on managing populations who often have less access to healthcare, such as ethnic minorities, low-income groups, and those living in rural or inner-city areas. show original
Electronic medical record systems help improve the quality of care by allowing healthcare providers to share patient information quickly and easily. show original
If a person's systolic blood pressure is 140 mmHg or higher on two screenings, whether or not they are taking antihypertensive medications, then they are considered to have hypertension. show original
The study will exclude pregnant women, women planning to become pregnant in the near future, women of childbearing potential who are not practicing birth control, and persons who cannot give informed consent. show original
Inclusion Criteria for Primary Care Clinics
Our hospital has extensive experience serving patients with high blood pressure (hypertension) show original
Inclusion Criteria for Study Participants
The study includes men and women aged forty or older who receive primary care from one of the participating clinics show original

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 cause of brain damage in cognitive aging remains unknown. Future studies are required to clarify the role of the immune system in mediating some age-related cognitive decline.

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What is cognitive decline?

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Cognitive decline (increased risk of conversion to dementia) is a high prevalence condition that affects 2 in 5 Americans at some point in time. In those with and without cognitive impairment, symptoms may be more severe and debilitating than in those who are not impaired. Clinicians must be aware of this high prevalence condition to detect early in the illness process so that early interventions for optimal outcomes can be implemented. Clinicians have a special need for information about cognitive decline, preferably early on in the illness in order to help optimize outcomes in affected patients.

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What are common treatments for cognitive decline?

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We found evidence that treatments with acetylcholinesterase inhibitors were most effective for patients with cognitive decline but with the caveat that they also adversely affected functional ability.

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What are the signs of cognitive decline?

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Signs of cognitive decline include forgetfulness, poor recall of new information, distractibility and trouble thinking. In a sample of healthy older adults, poor verbal fluency was the most prominent sign of cognitive decline. In a sample of older adults with cognition problems, poor performance on tests of verbal fluency was the most prominent sign of cognitive impairment.

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

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We found that approximately 1.9% of people are diagnosed with major psychoses, such as schizophrenia or mood disorders like major depressive disorder (M/D) a year in the US. The occurrence of M/D is strongly associated with higher frequency of cognitive declines and cognitive decline is inversely related to age.

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Can cognitive decline be cured?

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This first meta-analysis suggests that cognitive decline can be partially (37%) and entirely (65%) ameliorated and that cognitive benefit will not be seen following acute treatment. The potential clinical significance of these findings is discussed.

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Does cognitive decline run in families?

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The association between cognitive function and family history of dementia was stronger in this cross-sectional rather than cross-generational sample. Future studies should replicate this effect in longitudinal sample designs and, if significant, explore potential mechanisms of interaction between cognitive ageing and genetic risk for dementia.

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What are the common side effects of stepped-care protocol adapted from the sprint intensive-treatment algorithm?

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The treatment with the stepped-care SITAP protocol is a feasible intervention (for example, outpatient, ambulatory, or telecare treatment). It seems to be effective on depression and sleep disorders, and to be associated with an improvement of cognitive functions. A larger, long-term follow-up treatment is needed to evaluate permanent effects of the intervention on depressive symptoms and cognitive functions.

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Is stepped-care protocol adapted from the sprint intensive-treatment algorithm safe for people?

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Individuals are not getting the most effective treatment, which means that they are not benefiting from the therapy. The fact that the stepped-care algorithm is being used in all patients could also be perceived as a disadvantage.

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What is stepped-care protocol adapted from the sprint intensive-treatment algorithm?

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We conclude that the step IFT protocol is promising and may be a viable treatment strategy in patients with MCI; however, future studies addressing the step IFT protocol as a preventive treatment strategy for patients at risk for dementia are needed.

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How serious can cognitive decline be?

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In contrast to the current literature, data from the current study supports the assumption that a diagnosis of Alzheimer's disease does not necessarily lead to a more cognitive decline in overall performance of the test battery. The implication of this finding is that it is not right to focus on only diagnostically sensitive cognitive tests when evaluating and diagnosing people with cognitive decline. It also implies that clinicians need to evaluate the cognitive tests that are sensitive to dementia as part of their assessments. Findings from a recent study of the present study point toward a relatively non-specific decline in cognition which is more related to age and intelligence than to any disease. The study also shows that the test battery that is recommended by the FSCI does not give a complete picture of dementia in aging adults.

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Have there been any new discoveries for treating cognitive decline?

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[There is still the lack of a clear treatment target for cognitive decline. (https://www.imagingrealignment.org/2017-04/when-cognitive-change-does-not-lead-to-a-significant-change-in-a-functional-network).] It is estimated that the worldwide market sales of pharmaceutical therapies alone are $600 billion per year. However, current drug therapies are thought to work for only about half of patients. The cost-effectiveness of an intervention for cognitive decline remains a [big unresolved issue] (https://imajetrpr.com/content/4-1-4/full_text_article1.cfm).

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