Mild Cognitive Impairment (MCI)NCT07914218
Rural Veteran and Care Partner Walking Program
A study testing Telerehabilitation Physical Activity Behavioral Intervention in people with Mild Cognitive Impairment (MCI), run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Telerehabilitation Physical Activity Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60-95 years of age
- Mild cognitive impairment as staged by Clinical Dementia Rating (CDR, a gold standard cognitive outcome in ADRD clinical research) score of 0.5 or equivalent
- Characterized as underactive by the Telephone Assessment of Physical Activity (TAPA)
- Have a care partner willing to participate in physical activity and assist the participant
- Own a smartphone or tablet and willing to download a fitness tracker application
- Live in a rural area according to the VA Office of Rural Health rurality calculator
Show all 13Show fewer
- No self-reported falls in the last year
- Able to walk across a room in the home with no assistive device(s)
- Stable doses of medication over the previous 30 days
- Pass the Physical Activity Readiness Questionnaire+ (answering "no" to questions are pages 1-3)
- Interaction as a dyad (Veteran and care partner) at least on a weekly basis
- 19 years of age or older
- No cognitive impairment as indicated by a score of < 1 on the AD8 Dementia Screening Interview
Who cannot join
- Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Creighton University
Omaha, Nebraska, 68178
Rashelle Hoffman, PT, DPT, PhD, 402-280-5691, rashellehoffman@creighton.edu
About this study
Official title: Remotely Improving Physical Activity in Rural Veterans With Cognitive Impairment and Care Partner Dyads
The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas.
Participation includes:
- Complete a 6-week walking program
- Complete 2 testing visits (1 before and 1 after the 6-week walking program) consisting of various surveys and questionnaires
- Complete a semi-structured interview on feasibility and feedback of the intervention
- Potentially serve on an advisory board with the research team to assist with implementing the walking program adaptations
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Telerehabilitation Physical Activity Behavioral Intervention
- Keywords
- mild cognitive impairment, physical activity, veterans, walking, care partners, dyads
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation Physical Activity Behavioral InterventionBehavioural
Six dyads (n=12) will complete TPAB field testing and will undergo testing at baseline and post-intervention. Consent, baseline testing, intervention delivery, and post-testing will be conducted virtually via Microsoft Teams and data recorded in VA REDCap. Testing sessions will not be recorded, with the exception of semi-structured interviews during post-testing. The testing procedures will take approximately 2 hours to complete at each testing time point. The TPAB intervention will involve weekly 30-minute sessions with study personnel for 6 weeks. Due to the 7-day activity monitor data collection prior to and following the 6-week TPAB intervention, participants will be enrolled in the study for approximately 8 weeks. Three dyads will be asked to join the advisory board with the research team to assist with implementing the walking program adaptations based on the collective feedback across the 16 dyads.
| Study group | Role | What they receive |
|---|---|---|
| Field Testing Group | Experimental | Not described Receives: Behavioral: Telerehabilitation Physical Activity Behavioral Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly Session Attendance
The total number of sessions attended by dyads will be reported as a percentage of the 6 weekly sessions. Ranges of attendance could be 0% (not attending any sessions) to 100% attending all session. Attendance will be used to evaluate participant engagement and practicality of implementation.
Measured: From enrollment to end of the 6-week intervention
Study Retention
Defined as continued participation through the study completion. Calculated using withdrawal and completion records. Higher retention (such as 100% retention indicating all dyads that enrolled in the study, completed the study) supports intervention feasibility.
Measured: From enrollment to end of intervention at 8 weeks
Intrinsic Motivation Inventory (IMI)
Evaluates participant interest, enjoyment, perceived value, and engagement with the intervention. The IMI is comprised of 7 statements related to interest/enjoyment that the participant indicates how true the statement is to them regarding their experience participating in the intervention. Each statement is scored on a 1-7 scale and an average is computed across all the questions to determine the IMI score. Higher scores indicate greater intervention acceptability.
Measured: Post-intervention (week 8)
Number of participants with study-related adverse events
Includes falls, injuries, medical issues, skin irritation, or other unintended consequences. Used to evaluate intervention safety.
Measured: From enrollment to end of intervention at 8 weeks
Average Daily Stepping
Objective measure of physical activity captured through Fitbit devices. Average daily step counts are computed in the Fitbit application and will be recorded for each day and averaged over the 7-day monitoring period before and after the intervention provide proof-of-concept evidence of behavior change.
Measured: Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program)
Qualitative Intervention Feasibility Outcomes
Interviews evaluating demand, implementation, practicality, acceptability, adaptation, and integration. Findings will guide refinement of the intervention for future trials.
Measured: Post-intervention (for feedback)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start12 Jun 2026
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot clinical research study is structured as a feasibility trial to determine if the TPAB intervention is feasible for Veterans with mild cognitive impairment and their care partners in rural areas and to identify necessary adaptations. The trial is designed to inform adaptations and future larger-scale efficacy trial to assess longer time points for the sustainability of intervention impact.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Iowa City VA Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914218
- Sponsor's protocol ID
- Creighton IRB: 2005570
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Improving Physical Activity in Rural Veterans With Cognitive Impairment and Care Partner Dyads
- ClinicalTrials.gov ID
- NCT07914218
- Acronym / sponsor ID
- Creighton IRB: 2005570
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- mild cognitive impairment, physical activity, veterans, walking, care partners, dyads
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Iowa City VA Health Care System
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 3 Nov 2026 (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.
The purpose of this study is to determine the practicality/feasibility of a virtual physical activity intervention to improve daily steps for Veterans with mild cognitive impairment and their care partners living in rural areas.
Participation includes:
- Complete a 6-week walking program
- Complete 2 testing visits (1 before and 1 after the 6-week walking program) consisting of various surveys and questionnaires
- Complete a semi-structured interview on feasibility and feedback of the intervention
- Potentially serve on an advisory board with the research team to assist with implementing the walking program adaptations
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot clinical research study is structured as a feasibility trial to determine if the TPAB intervention is feasible for Veterans with mild cognitive impairment and their care partners in rural areas and to identify necessary adaptations. The trial is designed to inform adaptations and future larger-scale efficacy trial to assess longer time points for the sustainability of intervention impact.
| Arm | Type | Receives |
|---|---|---|
| Field Testing Group | Experimental | Behavioral: Telerehabilitation Physical Activity Behavioral Intervention |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 60-95 years of age
- Mild cognitive impairment as staged by Clinical Dementia Rating (CDR, a gold standard cognitive outcome in ADRD clinical research) score of 0.5 or equivalent
- Characterized as underactive by the Telephone Assessment of Physical Activity (TAPA)
- Have a care partner willing to participate in physical activity and assist the participant
- Own a smartphone or tablet and willing to download a fitness tracker application
Key exclusion criteria (1 listed)
- Neurodegenerative or acute neurological diagnoses (e.g., Parkinson's disease, stroke, traumatic brain injury)
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 |
|---|---|---|
| Telerehabilitation Physical Activity Behavioral InterventionSix dyads (n=12) will complete TPAB field testing and will undergo testing at baseline and post-intervention. Consent, baseline testing, intervention delivery, and post-testing will be conducted virtually via Microsoft Teams and data recorded in VA REDCap. Testing sessions will not be recorded, with the exception of semi-structured interviews during post-testing. The testing procedures will take approximately 2 hours to complete at each testing time point. The TPAB intervention will involve weekly 30-minute sessions with study personnel for 6 weeks. Due to the 7-day activity monitor data collection prior to and following the 6-week TPAB intervention, participants will be enrolled in the study for approximately 8 weeks. Three dyads will be asked to join the advisory board with the research team to assist with implementing the walking program adaptations based on the collective feedback across the 16 dyads. | Behavioural | Field Testing Group |
Primary outcome
Weekly Session Attendance
Time frame: From enrollment to end of the 6-week intervention
The total number of sessions attended by dyads will be reported as a percentage of the 6 weekly sessions. Ranges of attendance could be 0% (not attending any sessions) to 100% attending all session. Attendance will be used to evaluate participant engagement and practicality of implementation.
Study Retention
Time frame: From enrollment to end of intervention at 8 weeks
Defined as continued participation through the study completion. Calculated using withdrawal and completion records. Higher retention (such as 100% retention indicating all dyads that enrolled in the study, completed the study) supports intervention feasibility.
Intrinsic Motivation Inventory (IMI)
Time frame: Post-intervention (week 8)
Evaluates participant interest, enjoyment, perceived value, and engagement with the intervention. The IMI is comprised of 7 statements related to interest/enjoyment that the participant indicates how true the statement is to them regarding their experience participating in the intervention. Each statement is scored on a 1-7 scale and an average is computed across all the questions to determine the IMI score. Higher scores indicate greater intervention acceptability.
Number of participants with study-related adverse events
Time frame: From enrollment to end of intervention at 8 weeks
Includes falls, injuries, medical issues, skin irritation, or other unintended consequences. Used to evaluate intervention safety.
Average Daily Stepping
Time frame: Pre (before starting the 6-week walking program) and Post Intervention (following completion of the 6-week walking program)
Objective measure of physical activity captured through Fitbit devices. Average daily step counts are computed in the Fitbit application and will be recorded for each day and averaged over the 7-day monitoring period before and after the intervention provide proof-of-concept evidence of behavior change.
Qualitative Intervention Feasibility Outcomes
Time frame: Post-intervention (for feedback)
Interviews evaluating demand, implementation, practicality, acceptability, adaptation, and integration. Findings will guide refinement of the intervention for future trials.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation Physical Activity Behavioral Intervention in people with Mild Cognitive Impairment (MCI), run by Creighton University 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 13 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 3 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rashelle Hoffman, PT, DPT, PhD (402-280-5691, rashellehoffman@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly Session Attendance (time frame: From enrollment to end of the 6-week intervention). The study lists 6 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 3 Nov 2026.