Kidney ReplacementIMPACTNCT04166994
Pilot of IMPACT Intervention at the University of New Mexico
A study testing Exercise and diet in people with Kidney Replacement, run by University of New Mexico at 1 site in United States.
Trial summary
Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Replacement
- What is being tested?
- Exercise and diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 13 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Received kidney transplant at UNMH
- Greater than 18 years of age
- Mentally competent
Who cannot join
- Children under the age of 18
- Incarcerated patients
- Pregnant women
- Active systemic infection
- Non-skin malignancy or melanoma in the past 2 years
- Known cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.
Read the detailed description
In Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT), the investigators will pilot the feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT recipients' varied stability immediately post-transplant, and the need to individually monitor their post-transplant immunosuppression regimen, a critical component of IMPACT will be an individually-tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability. IMPACT will combine a personalized assessment of the patient's food preferences and access to exercise resources within their environment (based on a standard list of factors developed by the nutrition and rehabilitation experts) along with clinical specifications from the transplant team. The study is innovative because it addresses previous limitations, while adapting the intervention to meet the needs of the culturally-diverse ESKD population. The final innovation of the IMPACT Pilot is the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments, ensure adherence to the intervention, collect all questionnaire data, and enhance participant retention.
- Conditions
- Kidney Replacement
- Being tested
- Exercise and diet, No Intervention: Usual Care
- Keywords
- Diet, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and dietBehavioural
IMPACT Intervention
No Intervention: Usual CareOther
No exercise or diet specialization.
| Study group | Role | What they receive |
|---|---|---|
| IMPACT Intervention | Experimental | Incorporate a rehabilitation approach to slowly increasing KT recipients' physical activity in addition to individualized dietary intervention at every post-transplant appointment through six months post-transplant, with follow-up at 12 months post-transplant. Receives: Behavioral: Exercise and diet |
| Usual Care | Other | No exercise or diet specialization. Receives: Other: No Intervention: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Acceptability: Satisfaction
Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability
Measured: 12 months
Intervention Acceptability: Usability
System Usability Scale, rated 1-5, where higher scores indicate ease of usability
Measured: 12 months
Intervention feasibility: Retention
Retention rates
Measured: Through study completion, an average of 1 year
Intervention feasibility: Missing data
Estimates of the expected rates of missing data
Measured: Through study completion, an average of 1 year
Intervention feasibility: Attrition
Participant attrition will be measured by counting participants who do not continue with the study
Measured: Through study completion, an average of 1 year
Intervention feasibility: Participation
Time required for study participation during every intervention session
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Medical records outcomes: Weight
Percent weight change
Measured: Through study completion, an average of 1 year
Medical records outcomes: Lipids
Total cholesterol: Less than 200 mg/dL, LDL: Less than 100 mg/dL, HDL: 60 mg/dL or higher, Triglycerides: less than 150 mg/dL
Measured: Through study completion, an average of 1 year
Medical records outcomes: HbA1c
HbA1c
Measured: Through study completion, an average of 1 year
Patient reported outcomes: Sleep
Pittsburgh Sleep Quality Index will measure different aspects of sleep and becomes one composite score, where lower scores denote a healthier sleep quality
Measured: Baseline, 1 year
Patient reported outcomes: QOL
We will use the PROMIS Scale v1.2 Global Health measure to assess quality of life (QOL), which includes items relevant to patients with kidney disease, including overall health, physical limitations, work, pain, energy, and emotional problems.
Measured: Baseline, 1 year
Patient reported outcomes: Occupational
Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation
Measured: Baseline, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Nov 2020
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney ReplacementStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larissa Myaskovsky, PhD, University of New Mexico
- Investigators
- Larissa Myaskovsky, PhD, Principal investigator, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166994
- Sponsor's protocol ID
- 19-413 IMPACT
- Acronym
- IMPACT
- Status last verified
- Dec 2024
- First submitted
- 30 Oct 2019
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)
- ClinicalTrials.gov ID
- NCT04166994
- Acronym / sponsor ID
- IMPACT / 19-413 IMPACT
- Conditions
- Kidney Replacement
- Keywords
- Diet, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 18 Nov 2019 (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.
Kidney transplant recipients (KTR) are at greater risk of weight gain, diabetes and cardiovascular events post-transplant; but medications are limited in their effectiveness, and patients may face contraindications and unwanted side effects, given their complex post-transplant immunosuppression regimen. The investigators will pilot a randomized-controlled trial to test the feasibility and acceptability of a culturally-appropriate, multi-behavior (diet and exercise) lifestyle intervention for 20 American Indian, Hispanic/Latino(a), and White KTRs. Critical components of the pilot trial include: (a) an individually tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability; and, (b) the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments and to collect all questionnaire data.
Detailed description
In Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT), the investigators will pilot the feasibility and acceptability of a culturally-tailored, multi-behavior lifestyle intervention using a novel technology for 14-20 AI, HL, and White KT recipients. Because of KT recipients' varied stability immediately post-transplant, and the need to individually monitor their post-transplant immunosuppression regimen, a critical component of IMPACT will be an individually-tailored exercise and diet plan with a physical therapist/exercise physiologist and a registered dietitian nutritionist, who will work closely with the post-transplant team to carefully monitor patient stability. IMPACT will combine a personalized assessment of the patient's food preferences and access to exercise resources within their environment (based on a standard list of factors developed by the nutrition and rehabilitation experts) along with clinical specifications from the transplant team. The study is innovative because it addresses previous limitations, while adapting the intervention to meet the needs of the culturally-diverse ESKD population. The final innovation of the IMPACT Pilot is the use of the Twistle Patient Engagement Platform to follow-up with participants between their scheduled appointments, ensure adherence to the intervention, collect all questionnaire data, and enhance participant retention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial
| Arm | Type | Receives |
|---|---|---|
| IMPACT Intervention | Experimental | Behavioral: Exercise and dietIncorporate a rehabilitation approach to slowly increasing KT recipients' physical activity in addition to individualized dietary intervention at every post-transplant appointment through six months post-transplant, with follow-up at 12 months post-transplant. |
| Usual Care | Other | Other: No Intervention: Usual CareNo exercise or diet specialization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Received kidney transplant at UNMH
- Greater than 18 years of age
- Mentally competent
Key exclusion criteria (6 listed)
- Children under the age of 18
- Incarcerated patients
- Pregnant women
- Active systemic infection
- Non-skin malignancy or melanoma in the past 2 years
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 |
|---|---|---|
| Exercise and dietIMPACT Intervention | Behavioural | IMPACT Intervention |
| No Intervention: Usual CareNo exercise or diet specialization. | Other | Usual Care |
Primary outcome
Intervention Acceptability: Satisfaction
Time frame: 12 months
Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability
Intervention Acceptability: Usability
Time frame: 12 months
System Usability Scale, rated 1-5, where higher scores indicate ease of usability
Intervention feasibility: Retention
Time frame: Through study completion, an average of 1 year
Retention rates
Intervention feasibility: Missing data
Time frame: Through study completion, an average of 1 year
Estimates of the expected rates of missing data
Intervention feasibility: Attrition
Time frame: Through study completion, an average of 1 year
Participant attrition will be measured by counting participants who do not continue with the study
Intervention feasibility: Participation
Time frame: Through study completion, an average of 1 year
Time required for study participation during every intervention session
6 secondary outcomes
Medical records outcomes: Weight
Time frame: Through study completion, an average of 1 year
Medical records outcomes: Lipids
Time frame: Through study completion, an average of 1 year
Medical records outcomes: HbA1c
Time frame: Through study completion, an average of 1 year
Patient reported outcomes: Sleep
Time frame: Baseline, 1 year
Patient reported outcomes: QOL
Time frame: Baseline, 1 year
Patient reported outcomes: Occupational
Time frame: Baseline, 1 year
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 12 Dec 2024.
- 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. This study is not recruiting at the moment.
Larissa Myaskovsky, PhD principal investigator
University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and diet in people with Kidney Replacement, run by University of New Mexico 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 3 inclusion and 6 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 12 Dec 2024. 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?
Intervention Acceptability: Satisfaction (time frame: 12 months). 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 12 Dec 2024.