Feasibility and Effectiveness of a Telehealth-Delivered Inductive Reasoning Training Program for Older Adults

October 20, 2022 updated by: University of Florida
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 100 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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]).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telehealth Reasoning Training
Telehealth-delivered inductive reasoning training will focus on improving the ability to solve problems that require linear thinking and that follow a serial pattern or sequence. Participants will be taught strategies to identify patterns to solve problems. These problems involve identifying the pattern in series of numbers and letters, or recognizing patterns in everyday activities, like dosing for medications. Training will consist of ten training sessions, over 5 weeks, and will be conducted over Zoom. Each training session is 60-75 minutes long and typically consists of (a) 10 minutes of introductory training exercises for basic mental abilities, such as finding patterns in schedules, (b) training exercises for everyday tasks, such as filling out medication charts, recycling charts, and understanding medicine bottle labels, and (c) a 20-question practice assessment.
Behavioral: Telehealth Reasoning Training
The current study is explores the feasibility and preliminary relative effectiveness of a telehealth-delivered inductive reasoning intervention. The results of the study can help to provide insight on whether a telehealth-adapted reasoning training shows promise with older adults and can also be used to power future clinical trial studies to more definitively evaluate the effectiveness of telehealth delivered training.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Word Series" Measure
Time Frame: 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.
Word Series is a measure of reasoning, assessing what word would come next in a series.
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.
Telehealth -Usability Questionnaire
Time Frame: 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.
A questionnaire assessing telehealth satisfaction. Answer choices range from Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree. Higher scores = higher telehealth satisfaction.
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.
Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Letter Series" Measure
Time Frame: 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.
Letter Series is a measure of reasoning, assessing what letter would come next in a series.
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.
Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Letter Sets" Measure
Time Frame: 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.
Letter Sets is a measure of reasoning, assessing what set of letters is different from all the other sets of letters.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Vocabulary Performance to Post-Training Vocabulary Performance: "Vocabulary" Measure
Time Frame: 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.
The Vocabulary Measure is a measure of knowledge of word meanings.
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.
Change from Baseline self-rated Health to Post-Training self-rated Health: "36-Item Short Form Survey (SF-36)" Measure
Time Frame: 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.
A questionnaire regarding self-rated health. Answer choices vary across questions.
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.
Change from Baseline Personality in Intellectual-Aging Contexts to Post-Training Personality in Intellectual-Aging Contexts: "Personality in Intellectual-Aging Contexts" Questionnaire.
Time Frame: 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.
A questionnaire regarding Personality in Intellectual-Aging Contexts. Answer choice range from Strongly Disagree, Disagree, Slightly Disagree, Neutral, Slightly Agree, Agree, Strongly Agree.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brad Taylor, University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB202101691

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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