Reasoning TrainingNCT05334186
Feasibility and Effectiveness of a Telehealth-Delivered Inductive Reasoning Training Program for Older Adults
A study testing Telehealth Reasoning Training in people with Reasoning Training, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Reasoning Training
- What is being tested?
- Telehealth Reasoning Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2022to 26 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 years of age or older; have computer and internet; and are available during the duration of the study.
Who cannot join
- 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]).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Reasoning Training
- Being tested
- Telehealth Reasoning Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Reasoning TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Reasoning Training | Experimental | 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. Receives: Behavioral: Telehealth Reasoning Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Reasoning Performance to Post-Training Reasoning Performance: "Word Series" Measure
Word Series is a measure of reasoning, assessing what word would come next in a series.
Measured: 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
A questionnaire assessing telehealth satisfaction. Answer choices range from Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree. Higher scores = higher telehealth satisfaction.
Measured: 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
Letter Series is a measure of reasoning, assessing what letter would come next in a series.
Measured: 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
Letter Sets is a measure of reasoning, assessing what set of letters is different from all the other sets of letters.
Measured: 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 (3)
Change from Baseline Vocabulary Performance to Post-Training Vocabulary Performance: "Vocabulary" Measure
The Vocabulary Measure is a measure of knowledge of word meanings.
Measured: 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
A questionnaire regarding self-rated health. Answer choices vary across questions.
Measured: 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.
A questionnaire regarding Personality in Intellectual-Aging Contexts. Answer choice range from Strongly Disagree, Disagree, Slightly Disagree, Neutral, Slightly Agree, Agree, Strongly Agree.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start25 Feb 2022
- Primary completion26 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reasoning TrainingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brad Taylor, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334186
- Sponsor's protocol ID
- IRB202101691
- Status last verified
- Oct 2022
- First submitted
- 10 Mar 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Telehealth-Delivered Inductive Reasoning Training Program for Older Adults
- ClinicalTrials.gov ID
- NCT05334186
- Acronym / sponsor ID
- IRB202101691
- Conditions
- Reasoning Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 26 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telehealth Reasoning Training | Experimental | Behavioral: Telehealth Reasoning TrainingTelehealth-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. |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65 years of age or older; have computer and internet; and are available during the duration of the study.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth Reasoning TrainingThe 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. | Behavioural | Telehealth Reasoning Training |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Taylor principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Reasoning Training in people with Reasoning Training, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.