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Completed

NCT Number: NCT02265757

Behavioral Interventions to Prevent or Delay Dementia

This study will compare the effectiveness of different combinations of 5 types of behavioral interventions across patient-centered outcomes. It will also evaluate which outcomes (e.g. quality of life, cognition, function, mood) matter most to people at risk for dementia and their care partners. The results of this study have the potential to direct patients, families, and health care providers as to which combinations of behavioral interventions provide the greatest potential impact on which dementia prevention outcomes. Greater use of behavioral strategies that are targeted to the outcomes of most important to the patient will likely improve patient compliance and treatment adherence. This, in turn, can lessen the need for medication, health care, and long term care utilization.

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Key information

Conditions

Mild Cognitive Impairment Amnestic Disorder Behavior Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Dementia and Amnestic Conditions Habits Impaired Cognition Memory Disorders Memory Impairment Mental Disorders Mild Cognitive Disorder Mild Dementia Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Poor Short-term Memory Signs and Symptoms

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

Traditional randomized controlled trials (RCTs) can be thought of as 'additive' trials where randomization leads to the addition of treatments beyond placebo. Participants are confronted with the probability of receiving placebo (no treatment). This leads many potential participants to not consent or to withdraw if they believe they are receiving no treatment. In contrast, the proposed trial will be 'subtractive'. This innovative approach to randomization will involve suppression of just 1 of the 5 treatment components. Thus, all participants will receive at least 80% of the menu of interventions offered in this trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A candidate for the HABIT program with a diagnosis of amnestic MCI (confirmed at eligibility visit by a Clinical Dementia Rating (CDR) scale of 0.5).

A cognitively normal care partner who has at least twice-weekly contact with the participant.

Either not taking or stable on memory medicine(s) (e.g. donepezil) for at least 3 months.

Fluent in English. (Expanding the program to communities of Spanish- speakers will be a high priority in subsequent dissemination work).

Exclusion criteria

Inclusion in another clinical trial that would exclude participation. Subject will be considered for participation at the end of such a trial or as appropriate.

Medically unable to participate in all arms by virtue of visual or auditory impairments or non-ambulatory status.

Treatment and study plan

Cognitive Rehabilitation

Behavioral

Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here.

Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual.

Other names: Memory Compensation Training, Memory Support System

Computer Brain Fitness Training

Behavioral

Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.

Other names: Brain Fitness

Support Group (patient and partner)

Behavioral

Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.

Wellness Education

Behavioral

The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.

Physical exercise

Behavioral

The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.

Other names: Yoga

Primary outcomes

  1. Improvement in patient quality of life

    Time frame: baseline to 18 months

    quality of life measured by the QOL-AD scale

Secondary outcomes

  1. improvement in patient memory based everyday functioning

    Time frame: baseline to 18 months

    measured by the Everyday Cognitive Functioning scale (ECOG)

  2. improvement in caregiver mood and sense of burden

    Time frame: baseline to 18 months

    measured by the Caregiver Burden questionnaire and the Center for Epidemiological Studies Depression scale (CESD)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Comparative Effectiveness of Behavioral Interventions to Prevent or Delay Dementia (CEBIPODD)

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2014
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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