Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-29 @ 2:34 AM
Study NCT ID:
NCT04719403
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2021-01-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-01-20', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Enrollment (Feasibility)', 'timeFrame': 'Study Completion, an average of 1 year', 'description': 'Meeting the targeted recruitment number and rate (two patients per month over a 12 month period)'}, {'measure': 'Intervention Fidelity (Feasibility)', 'timeFrame': 'Three months', 'description': 'The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm that received the VIDEO intervention with full adherence to a pre-defined protocol fidelity checklist. Any deviations will be documented.'}, {'measure': 'Patient use of the Intervention (Acceptability)', 'timeFrame': 'Three months', 'description': 'The proportion of ALS MDC (multidisciplinary clinic) patients in the intervention arm who used the recording between the day of receipt and the three-month follow up'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Patient Satisfaction, as measured by the Patient Satisfaction Questionnaire-18 (PSQ-18)', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on an 18-item, 5-level scale, with a score of 1 indicating "strongly agree" and a score of 5 indicating "Strongly Disagree". Scores range from 18 to 90, with lower scores indicating higher levels of satisfaction.'}, {'measure': 'Change from baseline in adherence to treatment, as measured by the Medical Outcomes Study - General Adherence', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on a 5-item, 6-level scale, with a score of 1 indicating "None of the time" and a score of 6 indicating "All of the time". Scores range from 6 to 30, with higher scores indicating higher levels of adherence. Items 1 and 3 are scored in reverse.'}, {'measure': 'Change from baseline in adherence to medications, as measured by the Adherence to Refills and Medications Scale - 7 (ARMS-7)', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on a 7-item, 4-level scale, with a score of 1 indicating "None" and a score of 4 indicating "All". Scores range from 7 to 28, with lower scores indicating higher levels of adherence.'}, {'measure': 'Change from baseline in adherence to physical therapy, as measured by the Exercise Adherence Rating Scale (EARS)', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on a 6-item, 5-level scale, with 0 indicating "Completely agree" and 4 indicating "Completely disagree". Scores range from 0 to 30, where a higher score indicates a higher level of adherence.'}, {'measure': 'Change from baseline in anxiety, as measured by the Generalized Anxiety Disorder - 7 (GAD-7)', 'timeFrame': 'Baseline, three months', 'description': 'Scores are based on a 7-item, 4-level scale with 0 indicating "Not at all" and 3 indicating "Nearly every day". Higher scores indicate higher levels of anxiety.'}, {'measure': 'Change from baseline in functional status, as measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS)', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on a 13-item, 5-level scale, with 0 indicating low function and 4 indicating high functioning, and one item as "yes/no". Scores range from 0 to 48, with high scores indicating higher levels of functioning.'}, {'measure': 'Change from baseline in depression, as measured by the Patient Health Questionnaire - 8 (PHQ-8)', 'timeFrame': 'Baseline, three months', 'description': 'Scores are based on a 8-item, 4-level scale with 0 indicating "Not at all" and 3 indicating "Nearly every day". Higher scores indicate higher levels of depression.'}, {'measure': 'Level of Communication in the Visit, as measured by the Interpersonal Processes of Care (IPC)', 'timeFrame': 'One week', 'description': 'Scores are based on an 18-item, 5-level scale with 1 indicating "Never" and 5 indicating "Always". Scores range from 18 to 90, with higher scores indicating higher levels of communication.'}, {'measure': 'Level of literacy, as measured by the Single Item Literacy Screener', 'timeFrame': 'Baseline', 'description': 'Scores are measured on a single item, 5-level scale. Scores range from 1 to 5, with higher scores indicating higher levels of literacy.'}, {'measure': 'Change in caregiver burden, as measured by the Burden Scale for Family Caregivers - Short (BSFC-s)', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are based on a 10-item, 4-level scale, with 0 indicating strongly disagree and 3 indicating strongly agree. Scores range from 0 to 30, with higher scores indicate higher levels of burden.'}, {'measure': 'Change in caregiver preparedness, as measured by the Preparedness for Caregiving Scale', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are based on a 9-item, 5-level scale, with 0 indicating not at all prepared, and 4 indicating very well prepared. Scores range from 0 to 45, with higher scores indicating higher levels of preparedness.'}, {'measure': 'Change in self-efficacy, as measured by the Self Efficacy for Managing Chronic Disease scale', 'timeFrame': 'Baseline, one week, three months', 'description': 'Scores are measured on 6x 10-item scales. Scores range from 0 to 60, with higher scores indicating higher levels of self-efficacy.'}, {'measure': 'Feasibility of the Intervention, as measured by the Feasibility of Intervention Metric (FIM)', 'timeFrame': 'Three months from baseline', 'description': 'Scores are measured on a 4-item, 5-level scale, with a score of 1 indicating "completely disagree" and 5 indicating "completely agree". Scores range from 4 to 20, with higher scores indicating higher levels of feasibility.'}, {'measure': 'Acceptability of the Intervention, as measured by the Acceptability of Intervention Metric (AIM)', 'timeFrame': 'Three months from baseline', 'description': 'Scores are measured on a 4-item, 5-level scale, with a score of 1 indicating "completely disagree" and 5 indicating "completely agree". Scores range from 4 to 20, with higher scores indicating higher levels of acceptability.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurology', 'health communications'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '38924779', 'type': 'DERIVED', 'citation': 'Bratches RWR, Cohen J, Carpenter-Song E, Mistler L, Barr PJ. The Feasibility and Acceptability of Sharing Video Recordings of Amyotrophic Lateral Sclerosis Clinical Encounters With Patients and Their Caregivers: Pilot Randomized Clinical Trial. JMIR Form Res. 2024 Jun 26;8:e57519. doi: 10.2196/57519.'}]}, 'descriptionModule': {'briefSummary': 'Our objective in the proposed project is to: (a) operationalize and determine the feasibility and acceptability of a trial where clinic multi-disciplinary clinic (MDC) visits are audio/video recorded and shared with patients with ALS and their caregivers; (b) gather preliminary data examining the impact of routinely adding audio/video recordings of clinic visits to UC on self-management ability and other behavioral, health and health services outcomes at baseline (T0) and other regular interviews from enrollment (T1= 1 Week, T2= 3 Months); and (c) identify factors pertinent to the acceptability of our study protocol and the audio/video recording of visits.', 'detailedDescription': "We will conduct a single-site, two-arm, parallel group, patient-randomized, controlled, pilot trial with 3-month follow up, to determine the feasibility, acceptability, and potential effectiveness of sharing audio/video recordings of multidisciplinary ALS clinics with patients and their caregivers. We will recruit 24 patients with ALS and their caregivers over a recruitment period of 1 year. We are primarily interested in determining the feasibility of the trial and acceptability of the audio/video intervention. We will also explore the impact on the patients' ability to self-manage their care as well as exploratory outcomes, at baseline (T0 = pre-visit), at T1 (1 week), and at T2 (3 months)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed and primarily treated for Amyotrophic Lateral Sclerosis (ALS)\n* Aged 18 years or greater\n* Can communicate in English (verbally, on a computer, or with assistance)\n* Have email\n* Have internet access\n* Willing to have their multidisciplinary clinic visit audio/video recorded for a 3 month period\n\nExclusion Criteria:\n\n* Those without the capacity to provide consent, either themselves or via proxy'}, 'identificationModule': {'nctId': 'NCT04719403', 'briefTitle': 'Determining Feasibility and Acceptability of Sharing Video Recordings With Patients With ALS and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Determining the Feasibility, Acceptability, and Potential Effectiveness of Sharing Video Recordings of Multidisciplinary ALS Clinics With Patients and Their Caregivers', 'orgStudyIdInfo': {'id': 'STUDY02000798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIDEO', 'description': 'Participants receive access to video recordings of their clinic visits', 'interventionNames': ['Other: HealthPAL']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Participants receive usual care (UC), which is their normal clinic visit and written after-visit summary'}], 'interventions': [{'name': 'HealthPAL', 'type': 'OTHER', 'description': 'Participants who are randomly assigned to the HealthPAL arm will have immediate post- visit access to audio/video-recordings of their clinical visit through a HIPAA-compliant web-based program called HealthPAL.', 'armGroupLabels': ['VIDEO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'Jeffrey Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}, {'name': 'Paul J Barr, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Diamond Endowment Project', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, The Dartmouth Institute for Health Policy and Clinical Practice', 'investigatorFullName': 'Paul J. Barr', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}