Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 10:59 PM
Study NCT ID:
NCT05240534
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2022-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071069', 'term': 'Multiple Chronic Conditions'}], 'ancestors': [{'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-02-04', 'studyFirstSubmitQcDate': '2022-02-04', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in NIH Toolbox Loneliness Survey scores', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'NIH Toolbox Loneliness Survey is a self-report measure that assesses perceptions of loneliness. Participants rate items on a 5-point scale, with options ranging from never (1) to always (5). This creates a raw score, which is then converted to a t-score, with higher scores indicating greater levels of loneliness.'}, {'measure': 'ElderTree usefulness', 'timeFrame': '6, 12, 18 months', 'description': 'This is a 9 item scale created for the study to assess the usefulness of ElderTree. Participants rate items on a 4-point scale, with options ranging from not at all (1) to very much so (4), with higher scores indicating finding ElderTree useful.'}], 'primaryOutcomes': [{'measure': 'Change in functional health as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of overall health and level of physical disability. There are 4 questions with a possible score of 4-16. Lower scores indicate worse outcomes.'}, {'measure': 'Change in pain interference as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of pain interference, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.'}, {'measure': 'Change in pain intensity as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of pain intensity, this is a single question, with a possible score of 0 to 10. Higher scores indicate worse outcomes.'}, {'measure': 'Change in fatigue as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of fatigue, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.'}, {'measure': 'Change in sleep as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of sleep disturbance, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.'}, {'measure': 'Change in anxiety as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of anxiety, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.'}, {'measure': 'Change in depression as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1.', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Participant reported measure of depression, there are 4 questions, with a possible score of 4-20. Higher scores indicate worse outcomes.'}], 'secondaryOutcomes': [{'measure': 'Change in overall ElderTree use across the 12-month intervention', 'timeFrame': 'up to 12 months', 'description': 'Amount of ElderTree use will be calculated by number of logons in the ET portal.'}, {'measure': 'Change in healthcare use (primary care, specialist, urgent care, emergency room visits, and 30-day readmissions', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Data will be collected from electronic health record.'}, {'measure': 'Change in health distress', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Lorig Health Distress Scale is a self-reported measure. It has questions about how participant feel and how things have been during the past month. It is a 4 item scale. Each item can be score from 0-none of the time to 5- all the time. Higher scores corresponds to more amount of time the participant has been distressed about health (e.g.,discouraged, worried, fearful, frustrated by health problems).'}, {'measure': 'Change in function and disability', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'Late Life Function and Disability Instrument (FDI) evaluates self-reported difficulty a person has in performing activities of daily living tasks. There are 41 items with response options of "none," "a little," "some," "quite a lot," and "cannot do." An additional eight items for participants who use a walking device. Scores range from 1-5 with higher scores indicating higher levels of functioning.'}, {'measure': 'Change in well-being', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': "The World Health Organization- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental well being. The WHO-5 consists of five statements, which respondents rate from 'All of the time = 5' to 'At no time = 0'. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being."}, {'measure': 'Change in symptom distress', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'General Symptom Distress Scale \\& Bayliss Disease Burden Scale is a 16-item which assesses the extent of distress caused by physical symptoms. The higher scores indicating more symptom distress or burden.'}, {'measure': 'Change in falls', 'timeFrame': 'Baseline, 6, 12, 18 months', 'description': 'The number of falls in the last 6 months'}, {'measure': 'ElderTree ease of use', 'timeFrame': '6, 12, 18 months', 'description': 'This is a 9 item scale created for the study to assess the ease of use of ElderTree. Participants rate items on a 4-point scale, with options ranging from not at all (1) to very much so (4), with higher scores indicating finding ElderTree useful.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Voice-activated "smart" technology', 'Older adults'], 'conditions': ['Chronic Conditions, Multiple']}, 'referencesModule': {'references': [{'pmid': '40080672', 'type': 'DERIVED', 'citation': 'Gustafson DH Sr, Mares ML, Johnston DC, Curtin JJ, Pe-Romashko K, Landucci G. Comparison of Smart Display Versus Laptop Platforms for an eHealth Intervention to Improve Functional Health for Older Adults With Multiple Chronic Conditions: Protocol for a Randomized Clinical Trial. JMIR Res Protoc. 2025 Apr 3;14:e64449. doi: 10.2196/64449.'}]}, 'descriptionModule': {'briefSummary': 'Multiple chronic conditions (MCCs) are costly and pervasive among older adults. MCCs account for 90% of Medicare spending, and 65% of Medicare beneficiaries have 3 or more chronic conditions; 23% have 5 or more. MCCs are often addressed in primary care, where time pressures force a focus on medication and lab results rather than self-management skills. Patients often struggle with treatment adherence and the emotional and physical burdens of self-management and health tracking. Chronic conditions reduce quality of life (QOL) and increase loneliness, which exacerbate those conditions.\n\nThe primary purpose of this study is to investigate whether a voice-based platform is better for delivering an electronic health intervention to older adults than a text/typing-based platform. We have an evidence-based electronic health intervention (Elder Tree, ET) that has been shown to improve quality of life, physical and socio-emotional health outcomes for older adults with multiple chronic conditions when delivered via a text/typing-based system. The current project would test whether such patients would benefit even more if ET were delivered via a voice-based system (vs. the text-based system) because they would use it more consistently. ET is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be ≥60 years old;\n* Have medical record diagnoses of at least 5 chronic conditions of which at least 3 must come from the following: hypertension, hyperlipidemia, obesity, prediabetes or diabetes, or depression;\n* Be willing to share medical record data about healthcare use (30-day hospital readmissions and ER, urgent care, primary care, and specialty care visits);\n* Allow researchers to share information with the patient's primary care provider\n\nExclusion Criteria:\n\n* Require an interpreter\n* Report no current psychotic disorder that would prevent participation\n* Have no acute medical problem requiring immediate hospitalization\n* Not report impairments preventing use of a computer or tablet (e.g. blind, deaf)"}, 'identificationModule': {'nctId': 'NCT05240534', 'briefTitle': 'ElderTree Via a Voice Activated Device for Managing Chronic Health Conditions (NHLBI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Using Smart Displays to Implement Evidence-Based eHealth System for Older Adults With Multiple Chronic Conditions (NHLBI)', 'orgStudyIdInfo': {'id': '2020-0984'}, 'secondaryIdInfos': [{'id': 'A195000', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': 'Protocol Version 3/2/2023', 'type': 'OTHER', 'domain': 'UW Madison'}, {'id': '1R61HL151870-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R61HL151870-01A1', 'type': 'NIH'}, {'id': '5R33HL151870', 'link': 'https://reporter.nih.gov/quickSearch/5R33HL151870', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group (ET-Text)', 'description': 'Participants will receive ElderTree on a laptop.', 'interventionNames': ['Behavioral: ET-Text (Laptop)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group (ET-Voice)', 'description': 'Participants will receive ElderTree on a smart system.', 'interventionNames': ['Behavioral: ET-Voice (Smart System)']}], 'interventions': [{'name': 'ET-Text (Laptop)', 'type': 'BEHAVIORAL', 'description': 'ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users\' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Text arm will access ET on Laptop.', 'armGroupLabels': ['Control group (ET-Text)']}, {'name': 'ET-Voice (Smart System)', 'type': 'BEHAVIORAL', 'description': 'ElderTree (ET) is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a "walled garden" free of ads, with design features based on older users\' feedback as well as best-practice principles such as uncluttered screens and large type. Like all CHESS systems, ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-Voice arm will access ET on a smart speaker. Voice-activated devices can potentially be easy to use, even by those with limited dexterity or computer experience.', 'armGroupLabels': ['Experimental group (ET-Voice)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'David H Gustafson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}