Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-02-11 @ 7:11 AM
Study NCT ID:
NCT04187859
Status:
UNKNOWN
Last Update Posted:
2020-01-23
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prompting And encouRaging Community Hydration Through EDucation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-21', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-03', 'lastUpdatePostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment of participants', 'timeFrame': '12 Weeks'}, {'measure': 'Retention of participants', 'timeFrame': '12 Weeks'}, {'measure': 'Retention of District Nurses', 'timeFrame': '12 Weeks'}, {'measure': 'Acceptability and practicality of intervention for participants', 'timeFrame': '12 Weeks', 'description': 'Participants will be approached to complete semi structured interviews which will explore the mechanisms and outcomes of the interventions.'}, {'measure': 'Data Collection', 'timeFrame': '12 weeks', 'description': 'Completion of Case Report Forms'}], 'secondaryOutcomes': [{'measure': 'Hydration risk score (G, U and L of the GULP tool)', 'timeFrame': '12 weeks'}, {'measure': 'Tilburg Frailty Indicator Questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Fluid and food frequency questionnaires', 'timeFrame': '12 weeks', 'description': 'BEV-15'}, {'measure': 'Fluid and food frequency questionnaires', 'timeFrame': '12 weeks', 'description': 'SSFFQ'}, {'measure': 'Hydration self-efficacy Questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Quality of life Questionnaire', 'timeFrame': '12 weeks', 'description': 'EQ5D'}, {'measure': 'PANAS mood questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Montreal cognitive assessment', 'timeFrame': '12 weeks'}, {'measure': 'Semi-structured longitudinal interviews with District Nurses', 'timeFrame': '12 weeks'}, {'measure': 'Long-term follow up by NHS databases', 'timeFrame': '12 months'}, {'measure': 'Healthcare cost questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Evaluation Questionnaire', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hydration', 'Fluid Intake', 'Frailty', 'Feasibility Study'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'PARCHED (Prompting And encouRaging Community Hydration through EDucation) is studying how to improve the hydration (fluid intake) of people living at home who use catheters. The investigator would like to see if improved hydration (fluid intake) reduces the risk of frailty.\n\nPARCHED will randomise four areas in Cwm Taf University Health Board to receive one of four different interventions. Individuals will receive an intervention based on which area they live in, each participant will take part in the study for 12 weeks.', 'detailedDescription': 'PARCHED is a cluster feasibility randomized control trial (RCT) exploring the potential of an innovative prompting cup and education as person-centred and holistic tools to empower nursing leadership to reduce frailty in a catheterised community-dwelling population. This project will investigate interventions to improve hydration as potentially economically viable solutions to reducing frailty in a vulnerable population. Interventions have been developed using behaviour change theory and techniques. 80 participants will be recruited and will receive one of three interventions or usual care for a period of 12 weeks, data will be collected at baseline, 4 weeks and 12 weeks. Questionnaires, semi-structured interviews, and routine hospital records will be collected or accessed as part of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PARCHED will recruit district nurse patients at medium or high risk of dehydration (using the G, U and L of the GULP tool1),\n* with a urinary catheter,\n* living at home in community or residential care,\n* aged 18 years or above\n\nExclusion Criteria:\n\n* Inability to provide informed consent,\n* medical conditions or dietary restrictions that would substantially limit ability to complete study requirements (i.e. intravenous fluid intake, inability to lift cup),\n* living in nursing care setting,\n* end of life pathway,\n* diagnosed swallowing difficulty,\n* inability to communicate in English or Welsh.'}, 'identificationModule': {'nctId': 'NCT04187859', 'acronym': 'PARCHED', 'briefTitle': 'Prompting And encouRaging Community Hydration Through EDucation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cwm Taf University Health Board (NHS)'}, 'officialTitle': 'A Feasibility Cluster RCT Investigating Improving Fluid Intake in Community-dwelling Urinary Catheterised District Nurse Patients Using an Innovative Prompting Cup, Education or a Combination of These Interventions.', 'orgStudyIdInfo': {'id': '257723'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Education Session', 'description': 'The participant will receive an education session in their home, lasting between 15-30 minutes from a District Nurse. The District Nurses will advise the participant on how to drink more fluids, the importance of hydration and the effects of dehydration.', 'interventionNames': ['Behavioral: Education Session']}, {'type': 'OTHER', 'label': 'Prompting Cup', 'description': 'Participants will receive a Droplet Cup with an electronic prompting device and a brief tutorial session from the District Nurse. The Droplet Cup will encourage the participant to stay hydrated during the day, by emitting a voice or light to encourage them to drink more.', 'interventionNames': ['Device: Prompting Cup']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'There will be no change to the care the participant receives from the District Nurse.'}, {'type': 'OTHER', 'label': 'Prompting Cup and Education', 'description': 'Participants will receive a Droplet Cup with an electronic prompting device and an education session on the importance of hydration and the effects of dehydration.', 'interventionNames': ['Behavioral: Education Session', 'Device: Prompting Cup']}], 'interventions': [{'name': 'Education Session', 'type': 'BEHAVIORAL', 'description': 'Participants will receive an education session from their District Nurse, advising on how to improve their hydration.', 'armGroupLabels': ['Education Session', 'Prompting Cup and Education']}, {'name': 'Prompting Cup', 'type': 'DEVICE', 'description': 'The Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink', 'armGroupLabels': ['Prompting Cup', 'Prompting Cup and Education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Merthyr Tydfil', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Claire Nott', 'role': 'CONTACT'}], 'facility': 'Cwm Taf Morgannwg University Health Board', 'geoPoint': {'lat': 51.74794, 'lon': -3.37779}}], 'centralContacts': [{'name': 'Christina Lloydwin, PhD', 'role': 'CONTACT', 'email': 'christina.lloydwin@wales.nhs.uk', 'phone': '01685 351456'}, {'name': 'Claire Nott, BSc', 'role': 'CONTACT', 'email': 'claire.nott@wales.nhs.uk', 'phone': '01685 351457'}], 'overallOfficials': [{'name': 'Rhian Beynon', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cwm Taf Morgannwg University Health Board'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cwm Taf University Health Board (NHS)', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'PRIME Centre Wales', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}