Telehealth-Adapted Compensatory Training and Intervention for Cognition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-84
SponsorUniversity of Florida
About this trial
The goal of this clinical trial is to develop a five-week virtual cognitive training intervention for people with Mild Cognitive Impairment (MCI) based off an existing eight-week intervention. The main question it aims to answer is:
• Is five weeks of training as good as eight weeks in improving cognition, quality of life, daily functioning, and mood, and in reducing caregiver burden? Researchers will compare five weeks of cognitive training to eight weeks of training to see if the shorter version is as effective as the full training.
Participants will complete all activities virtually:
* Complete a screening visit with a study partner (typically a family member, roommate, or close friend) to determine eligibility to participate in the study * Complete some tests of memory and thinking and some questionnaires * Attend weekly two-hour group cognitive training sessions with a trained group leader, for five or eight weeks * Redo the questionnaires and tests of memory and thinking immediately after completing the training, and three months after completing the training
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 years of age or older, less than 85 years
Have the ability to speak and understand English
Time and willingness to commit to the completion of this study
Availability of a study partner (typically a relative, spouse, offspring, or roommate) for initial and post-intervention testing
Disqualifiers
Self-reported diagnosis of dementia or functional impairment that requires assistance
Recent changes in medications for memory (i.e., prescribed or changed medications for memory within 30 days)
Major psychiatric illness (schizophrenia, current substance dependence, or undertreated depression or anxiety), or 15-item Geriatric Depression Scale (GDS-15) score of eight or higher
Hearing, vision, or motor deficits that would interfere with standardized cognitive assessment or participation in study interventions: e.g., inability to hear through headphones (with or without hearing aids). If vision is corrected with lenses to appropriate levels, then participant will be eligible
Trial design
Design model
Parallel
Treatments tested in this trial
Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT-MCI)
BehavioralME-CCT-MCI is a publicly available manual for people with mild cognitive impairment (MCI) which has shown effectiveness in improving cognitive performance. Course material will be from the manualized protocol by Huckans and Twamley et al. (2018). The manual includes brief motivational interviewing techniques and modules designed to support behaviors that enhance cognition, such as physical activity, strategies to support learning and memory, mindfulness, and the use of day planners and calendars. It includes the use of frequent breaks, and at-home practice exercises. Each weekly session will be completed in groups of 8-10 participants, and will be led by trained intervention leaders.
Brief Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (bME-CCT-MCI)
BehavioralbME-CCT-MCI is a shortened version of the full ME-CCT-MCI, from eight weeks to five weeks. It preserves core principles of cognitive compensation and habit learning, with a booster summary session in week 5 to reinforce retention. Other than the condensed material, sessions are the same as those in the full ME-CCT-MCI.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Brief cognitive training (5 weeks)Experimental treatment 1 intervention
Group B: Full cognitive training (8 weeks)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in cognition
As assessed by the National Alzheimer's Coordinating Center Uniform Data Set version 4 (NACC-UDSv4). This full neuropsychological assessment consists of neuropsychological tests including: Montreal Cognitive Assessment (MoCA)-BLIND, Craft Story 21, Benson Complex Figure, Number Span Test (Forward and Backward), Category Fluency, Trail Making Test, Verbal Fluency: Phonemic Test, Rey Auditory Verbal Learning Test (RAVLT), and Multilingual Naming Test (MINT). On most of these tasks a higher score indicates better cognition, except for on Trail Making Test, where a lower score indicates faster time (better cognition).
Time frame
Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)2
Change in quality of life
As assessed by the Quality of Life in Alzheimer's Disease (QOL-AD), completed by participant and study partner, where higher scores indicate better quality of life (range 13-52).
Time frame
Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)3
Change in subjective cognition
As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v2.0 Cognitive Function 8a, a self-report cognitive functioning questionnaire, where a higher score indicates better reported cognition (range 8-40).
Time frame
Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)4
Change in reported daily functioning
As assessed by the National Alzheimer's Coordinating Center (NACC) Functional Assessment Scale (FAS), completed by the study partner, where a lower score indicates more independence (range 0 to 30).
Time frame
Baseline, end of treatment (5 or 8 weeks after baseline, up to 7 or 10 weeks after baseline), and three months after end of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)Secondary outcomes
1
Individual characteristics that predict cognitive benefits of intervention
Assess moderation effects of education, baseline cognitive scores, baseline physical activity levels and sleep, and neuroimaging (Magnetic Resonance Imaging \[MRI\]) on predicting a greater benefit of intervention on cognition.
Time frame
BaselineOther outcomes
1
Treatment satisfaction
As assessed by the Client Satisfaction Questionnaire (CSQ-8), completed by participant and study partner, where a higher score indicates greater satisfaction (range 8 to 32).
Time frame
End of treatment (18 or 21 weeks after baseline, up to 20 or 23 weeks after baseline)2
Familiarity with Telehealth
Assess/control for how familiarity with virtual/telehealth formats may impact the effectiveness of treatment, as assessed via the Patient Telehealth Readiness Assessment tool created by the National Center for Farmworker Health. Scores range from 0 to 18, where 0 indicates minimal familiarity with telehealth platforms and 18 indicates good familiarity.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov