Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-25 @ 4:14 AM
Study NCT ID:
NCT04166994
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot of IMPACT Intervention at the University of New Mexico
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004032', 'term': 'Diet'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-13', 'size': 794660, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_004.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-05T14:02', 'hasProtocol': True}, {'date': '2021-04-08', 'size': 169853, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-08-02T10:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2019-10-30', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention Acceptability: Satisfaction', 'timeFrame': '12 months', 'description': 'Client Satisfaction Questionnaire, rated 1-4, where higher satisfaction will indicate greater intervention acceptability'}, {'measure': 'Intervention Acceptability: Usability', 'timeFrame': '12 months', 'description': 'System Usability Scale, rated 1-5, where higher scores indicate ease of usability'}, {'measure': 'Intervention feasibility: Retention', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Retention rates'}, {'measure': 'Intervention feasibility: Missing data', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Estimates of the expected rates of missing data'}, {'measure': 'Intervention feasibility: Attrition', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Participant attrition will be measured by counting participants who do not continue with the study'}, {'measure': 'Intervention feasibility: Participation', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Time required for study participation during every intervention session'}], 'secondaryOutcomes': [{'measure': 'Medical records outcomes: Weight', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Percent weight change'}, {'measure': 'Medical records outcomes: Lipids', 'timeFrame': 'Through study completion, an average of 1 year', 'description': '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'}, {'measure': 'Medical records outcomes: HbA1c', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'HbA1c'}, {'measure': 'Patient reported outcomes: Sleep', 'timeFrame': 'Baseline, 1 year', 'description': 'Pittsburgh Sleep Quality Index will measure different aspects of sleep and becomes one composite score, where lower scores denote a healthier sleep quality'}, {'measure': 'Patient reported outcomes: QOL', 'timeFrame': 'Baseline, 1 year', 'description': '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.'}, {'measure': 'Patient reported outcomes: Occupational', 'timeFrame': 'Baseline, 1 year', 'description': 'Occupational Functioning Subscale: CHART-SF rated 0-100, where higher scores indicate greater levels of participation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'Exercise'], 'conditions': ['Kidney Replacement']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Received kidney transplant at UNMH\n2. Greater than 18 years of age\n3. Mentally competent\n\nExclusion Criteria:\n\n1. Children under the age of 18\n2. Incarcerated patients\n3. Pregnant women\n4. Active systemic infection\n5. Non-skin malignancy or melanoma in the past 2 years\n6. Known cognitive impairment'}, 'identificationModule': {'nctId': 'NCT04166994', 'acronym': 'IMPACT', 'briefTitle': 'Pilot of IMPACT Intervention at the University of New Mexico', 'organization': {'class': 'OTHER', 'fullName': 'University of New Mexico'}, 'officialTitle': 'Improving Healthcare Outcomes in American Indian and Hispanic Transplant Recipients Using Culturally-Tailored Novel Technology (IMPACT)', 'orgStudyIdInfo': {'id': '19-413 IMPACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMPACT Intervention', 'description': "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.", 'interventionNames': ['Behavioral: Exercise and diet']}, {'type': 'OTHER', 'label': 'Usual Care', 'description': 'No exercise or diet specialization.', 'interventionNames': ['Other: No Intervention: Usual Care']}], 'interventions': [{'name': 'Exercise and diet', 'type': 'BEHAVIORAL', 'description': 'IMPACT Intervention', 'armGroupLabels': ['IMPACT Intervention']}, {'name': 'No Intervention: Usual Care', 'type': 'OTHER', 'description': 'No exercise or diet specialization.', 'armGroupLabels': ['Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}], 'overallOfficials': [{'name': 'Larissa Myaskovsky, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of New Mexico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of New Mexico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Director: CHEK-D', 'investigatorFullName': 'Larissa Myaskovsky, PhD', 'investigatorAffiliation': 'University of New Mexico'}}}}