Clinical trial NCT05334186: Feasibility and Effectiveness of a Telehealth-Delivered Inductive Reasoning Training Program for Older Adults
Official title: Feasibility and Effectiveness of a Telehealth-Delivered Inductive Reasoning Training Program for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reasoning Training
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study seeks to investigate 1) whether telehealth-delivered cognitive training in reasoning, adapted from the in-person reasoning training program from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) clinical trial, is perceived well by older adult participants and therefore potentially feasible for future larger studies, and 2) whether the older adult participants improve as a function of telehealth-delivered reasoning training. More specifically, it proposes to investigate participants' perceptions of and compliance with a telehealth-delivered cognitive training intervention in reasoning and whether that intervention is effective in improving reasoning compared to ACTIVE's traditional face-to-face training and no-contact control groups. Innovations of the proposed study are: (a) to provide important insight into the participants' perceptions of and compliance with a telehealth-based cognitive training intervention in reasoning for older adults that could potentially be adapted in the future for clinical settings, and (b) to shed light on the relative effectiveness of telehealth-based cognitive training in reasoning.

Detailed description: The proposed study is a pre-test post-test design exploring the feasibility and effectiveness of a telehealth-delivered inductive reasoning training program. The current study converts the widely disseminated in-person inductive reasoning training program from a large multisite clinical trial (ACTIVE) to a telehealth-delivered format. This study also benefits from the ability to compare telehealth delivered training to two propensity-matched comparison groups drawn from the ACTIVE sample of 2,802 adults aged 65 and older. The current study addresses whether telehealth-delivered training can achieve inductive reasoning improvements in older adults. In addition, because the delivery of the training is novel, and important aspect of this study is to assess how telehealth-delivered cognitive training in inductive reasoning is evaluated by older adult participants in terms of usefulness, ease of use \& learnability, interface quality, interaction quality, reliability, and satisfaction/anticipated future use of the telehealth intervention.

Eligibility criteria: Inclusion Criteria:

* 65 years of age or older; have computer and internet; and are available during the duration of the study.

Exclusion Criteria:

* 64 years of age or younger
* Score \< or = 22 on the Mini-Mental State Examination; have a diagnosis of Alzheimer's disease
* Have already experienced substantial functional decline (self-reported need for weight-bearing support or full caregiver performance of dressing, personal hygiene, or bathing 3 or more times in the previous 7 days)
* Have medical conditions that would predispose them to imminent functional decline or death (e.g., stroke within the past 12 months, certain cancers, or current chemotherapy or radiation treatment for cancer)
* Have recent cognitive training
* Are unavailable during the testing and intervention phases of the study
* Have severe losses in vision (self-reported difficulty in reading newsprint, or measured vision worse than 20/70 with best correction), hearing (interviewer-rated), or communicative ability (interviewer-rated) that would sufficiently impair performance to make participation impossible.
* Participants will also be excluded if they do not meet the criteria for telehealth readiness (being able to use Zoom and Canvas \[an e-learning platform\]).

Primary outcomes:
measure: Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Word Series" Measure
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
measure: Telehealth -Usability Questionnaire
timeFrame: This will be administered after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
measure: Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Letter Series" Measure
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
measure: Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Letter Sets" Measure
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
Secondary outcomes:
measure: Change from Baseline Vocabulary Performance to Post-Training Vocabulary Performance: "Vocabulary" Measure
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
measure: Change from Baseline self-rated Health to Post-Training self-rated Health: "36-Item Short Form Survey (SF-36)" Measure
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
measure: Change from Baseline Personality in Intellectual-Aging Contexts to Post-Training Personality in Intellectual-Aging Contexts: "Personality in Intellectual-Aging Contexts" Questionnaire.
timeFrame: This will be administered 1 day to 21 days prior to reasoning training starting and after the ten sessions of inductive reasoning training are conducted, during the post-training assessment, which is 1-21 days after the final (tenth) training session.
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Brad Taylor
role: PRINCIPAL_INVESTIGATOR
References: