Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2025-12-29 @ 8:18 PM
Study NCT ID:
NCT04452903
Status:
COMPLETED
Last Update Posted:
2021-01-13
First Post:
2020-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003142', 'term': 'Communication'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participant (patients of the physiotherapists) are unaware of the intervention.\n\nThe outcome assessor will not know who was in the intervention group and who was in the control'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2020-06-24', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Consultation reassurance questionnaire (0-72). Change is being assess before and after the intervention.', 'timeFrame': 'measure assessing change between two time points: base line and at two month.', 'description': "A questionnaire that measures patients' perceptions of consultation- higher values represent a better communication skills"}], 'secondaryOutcomes': [{'measure': 'The numeric pain rating scale (0-10)', 'timeFrame': '2 month', 'description': 'For the most severe and average pain intensity ( 0= no pain and 10 =the worst pain)'}, {'measure': 'Disability (0-10)', 'timeFrame': '2 month', 'description': 'For disability (0= no disability and 10 =the worst disability)'}, {'measure': 'Satisfaction (0-10)', 'timeFrame': '2 month', 'description': 'For satisfaction from the first consultation with the physiotherapist (0= no satisfied at all and 10 =very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['communication skills', 'Consultation reassurance questionnaire'], 'conditions': ['Communication']}, 'referencesModule': {'references': [{'pmid': '27405870', 'type': 'RESULT', 'citation': 'Holt N, Pincus T. Developing and testing a measure of consultation-based reassurance for people with low back pain in primary care: a cross-sectional study. BMC Musculoskelet Disord. 2016 Jul 12;17:277. doi: 10.1186/s12891-016-1144-2.'}, {'pmid': '23872104', 'type': 'RESULT', 'citation': 'Pincus T, Holt N, Vogel S, Underwood M, Savage R, Walsh DA, Taylor SJC. Cognitive and affective reassurance and patient outcomes in primary care: a systematic review. Pain. 2013 Nov;154(11):2407-2416. doi: 10.1016/j.pain.2013.07.019. Epub 2013 Jul 18.'}, {'pmid': '29509169', 'type': 'RESULT', 'citation': 'Holt N, Mansell G, Hill JC, Pincus T. Testing a Model of Consultation-based Reassurance and Back Pain Outcomes With Psychological Risk as Moderator: A Prospective Cohort Study. Clin J Pain. 2018 Apr;34(4):339-348. doi: 10.1097/AJP.0000000000000541.'}]}, 'descriptionModule': {'briefSummary': "The aim of this study is to test the effectiveness of a single training session in communication skills at improving patients' perceptions of physiotherapy consultations.", 'detailedDescription': "Population: Physiotherapists Detail: Physiotherapists (n=30) who work at 'Clalit' institute's (public health management organization in Israel) at four physiotherapy clinics.\n\nIntervention: A single session of training in consultation-based communication skills Detail: a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.\n\nComparison: No training Detail: The control group receives no extra training. Outcome: New patients' perception of consultations Detail: The Primary Outcome Measure is the Consultation-Based Reassurance Questionnaire (CRQ) The CRQ measures patients' perceptions of consultation. It consists of four subscales, each with three items: data-gathering, relationship-building, generic reassurance, and cognitive reassurance. The investigators are assessing change between two-time points (before and after the intervention). And also, the difference between study groups. This is collected twice: at baseline, and at follow up, from the intervention and control groups.\n\nType of Question: therapy Detail: The study tests whether a single training sessions can improve communication in consultations with physiotherapists.\n\nType of Study: RCT\n\nDetail: Stage 1: Pre-randomization:\n\nThe physiotherapists (n=30) will hand out a Consultation-Based Reassurance Questionnaire (CRQ) in a sealed envelope to each eligible patient (age 18+) they receive for the first consultation in two weeks period. The patient will complete the questionnaire in private, post consultation, and place it in a closed box. The physiotherapist will recruit a minimum of five patients each (n\\>150).\n\nBaseline measures are: age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the Consultation-Based Reassurance Questionnaire.\n\nStage 2: Randomization:\n\nThe process for randomization:\n\nFirst, participating physiotherapists will be matched for gender, seniority, and quality of reassurance in every clinic. They will then be allocated into one of the two arms at random (1:1), according to a computer random number list.\n\nStage 3: Follow up:\n\nAfter the intervention, both the intervention and control groups will again hand out the questionnaires (age, gender, pain area, chronicity, pain severity, disability, satisfaction from the consultation and the CRQ) to new eligible patients that arrive for the first consultation. The physiotherapist will recruit a minimum of ten patients each (total sample therefore n\\> 300, minimum number per arm=150).\n\nsample size The sample size was calculated with G\\*Power 3.1.9.4 using the t-test family to detect the difference between two independent means (two groups). The input parameters were as follows: for a two-tailed test, assuming a medium effect size of 0.5, α=0.05, and β=0.95, the total sample size recommended was 210 participants. One hundred five participants in each study group (intervention and control)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physiotherapists:\n\n * Working for Clalit Health Services. Dan-Petach Tikva region\n * Willing to participate in a 3-hour communication skills workshop\n* Patients:\n\n * over the age of 18\n * literate in Hebrew\n * Willing to participate in the study\n\nExclusion Criteria:\n\n* Unwilling to participate in the trial\n* Illiterate in Hebrew'}, 'identificationModule': {'nctId': 'NCT04452903', 'briefTitle': "A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations", 'organization': {'class': 'OTHER', 'fullName': 'Ariel University'}, 'officialTitle': "A Communication Enhancing Intervention to Improve Patients' Perception of Physiotherapy Consultations: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '0127-19-com2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reassurance intervention', 'description': 'The physiotherapist in the intervention group (n=15) will participate in a 3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.', 'interventionNames': ['Behavioral: communication skills']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The physiotherapist in the control group (n=15) receives no training.'}], 'interventions': [{'name': 'communication skills', 'type': 'BEHAVIORAL', 'description': '3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.', 'armGroupLabels': ['Reassurance intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Distric DAN - PETACH TIKVA', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}], 'overallOfficials': [{'name': 'Noa Ben Ami, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ariel University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ariel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}