Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT04799860
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2021-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-12-09', 'size': 156440, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-12-09T02:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A pre-post-intervention design with control group will be used to evaluate intervention uptake and implementation process effectiveness from the perspective of managers, primary care professionals, patients, and organisation. Primary care settings in central Sweden will be supported in implementing a guideline-based health-promoting way of working including screening of life-style habits, measures taken according to evidence based recommendations and documentation. Strategies will include interactive education sessions, external and internal facilitators, audit and feedback, and tools from theories of leading change; tailored according to contextual and participant needs.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Interviews to tailor strategies and evaluate implementation process', 'timeFrame': 'Interviews pre-intervention and up to 3 to 6 months after end of implementation support', 'description': 'Semi-structured interview guides directed to facilitators, co-workers and managers'}, {'measure': 'Interviews to evaluate implementation support, clinical process and thoughts about up-scaling', 'timeFrame': 'Interviews pre-intervention and up to 16 to18 months after end of implementation support', 'description': 'Semi-structured interview guides directed to facilitators, co-workers and managers'}, {'measure': 'Person centered processmapping', 'timeFrame': 'At baseline', 'description': 'Structured workshop with patient representatives'}, {'measure': 'Study specific logbook', 'timeFrame': 'Through study completion, in average 16 months', 'description': 'To measure fidelity, dose and reach and changes at the unit that may affect the implementation process'}], 'primaryOutcomes': [{'measure': 'Change and trend from baseline documented codes in medical records', 'timeFrame': 'Change from baseline (6 months), through study completion up to 6 months after end of implementation support', 'description': 'specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity'}, {'measure': 'Change and trend from baseline documented codes in medical records', 'timeFrame': 'Change from baseline (6 months), through study completion up to 18 months after end of implementation support', 'description': 'specific codes are used for measures related to the guideline recommendations for grade of advice for insufficient physical activity, unhealthy eating habits, hazardous use of alcohol and tobacco use and prescribed physical activity'}, {'measure': 'Change in S-NoMAD score (Swedish translation of NoMAD', 'timeFrame': 'Change from baseline S-Nomad score up to 4 to 6 months after end of study completion', 'description': '23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring'}, {'measure': 'Change in S-NoMAD score (Swedish translation of NoMAD', 'timeFrame': 'Change from baseline S-Nomad score up to 16 to 18 months after end of study completion', 'description': '23-item questionnaire covering the constructs coherence, cognitive participation, collective action and reflexive monitoring'}], 'secondaryOutcomes': [{'measure': 'Change in perceived clincial intervention by a study specific questionnaire', 'timeFrame': 'Change from baseline up to 4 to 6 months after end of implementation support', 'description': "Questions related to the patients' perception on receiving the clinical intervention or not"}, {'measure': 'Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.', 'timeFrame': 'Change from baseline in AIM,IAM and FIM up to 4 to 6 months after end of implementation support', 'description': 'Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct'}, {'measure': 'Change in perceived appropriateness (AIM), feasability (FIM) and acceptability (IAM) of the clinical intevention.', 'timeFrame': 'Change from baseline in AIM,IAM and FIM up to 16 to18 months after end of implementation support', 'description': 'Appropriateness, feasability, acceptability of the clinical intervention is rated on a 5-graded scale with 4 items per construct'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implementation', 'primary care', 'process evaluation'], 'conditions': ['Health Knowledge, Attitudes, Practice']}, 'referencesModule': {'references': [{'pmid': '25791983', 'type': 'BACKGROUND', 'citation': "Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258."}, {'pmid': '29385438', 'type': 'BACKGROUND', 'citation': 'Wandell PE, de Waard AM, Holzmann MJ, Gornitzki C, Lionis C, de Wit N, Sondergaard J, Sonderlund AL, Kral N, Seifert B, Korevaar JC, Schellevis FG, Carlsson AC. Barriers and facilitators among health professionals in primary care to prevention of cardiometabolic diseases: A systematic review. Fam Pract. 2018 Jul 23;35(4):383-398. doi: 10.1093/fampra/cmx137.'}, {'pmid': '31088483', 'type': 'BACKGROUND', 'citation': "Nilsen P, Schildmeijer K, Ericsson C, Seing I, Birken S. Implementation of change in health care in Sweden: a qualitative study of professionals' change responses. Implement Sci. 2019 May 14;14(1):51. doi: 10.1186/s13012-019-0902-6."}, {'pmid': '28851459', 'type': 'BACKGROUND', 'citation': 'Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.'}, {'pmid': '30509289', 'type': 'BACKGROUND', 'citation': 'Elf M, Nordmark S, Lyhagen J, Lindberg I, Finch T, Aberg AC. The Swedish version of the Normalization Process Theory Measure S-NoMAD: translation, adaptation, and pilot testing. Implement Sci. 2018 Dec 4;13(1):146. doi: 10.1186/s13012-018-0835-5.'}, {'pmid': '19664226', 'type': 'BACKGROUND', 'citation': 'Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.'}, {'pmid': '10474547', 'type': 'BACKGROUND', 'citation': 'Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.'}, {'pmid': '40197376', 'type': 'DERIVED', 'citation': 'Nilsagard YE, Smith DR, Soderqvist F, Strid EN, Wallin L. Achieving health-promotion practice in primary care using a multifaceted implementation strategy: a non-randomized parallel group study. Implement Sci Commun. 2025 Apr 7;6(1):36. doi: 10.1186/s43058-025-00723-y.'}, {'pmid': '38241166', 'type': 'DERIVED', 'citation': 'Nilsing Strid E, Wallin L, Nilsagard Y. Exploring expectations and readiness for healthy lifestyle promotion in Swedish primary health care: a qualitative analysis of managers, facilitators, and professionals. Scand J Prim Health Care. 2024 Mar;42(1):201-213. doi: 10.1080/02813432.2023.2301556. Epub 2024 Feb 7.'}, {'pmid': '37328813', 'type': 'DERIVED', 'citation': 'Strid EN, Wallin L, Nilsagard Y. Expectations on implementation of a health promotion practice using individually targeted lifestyle interventions in primary health care: a qualitative study. BMC Prim Care. 2023 Jun 16;24(1):122. doi: 10.1186/s12875-023-02079-5.'}, {'pmid': '35984700', 'type': 'DERIVED', 'citation': 'Strid EN, Wallin L, Nilsagard Y. Implementation of a Health Promotion Practice Using Individually Targeted Lifestyle Interventions in Primary Health Care: Protocol for the "Act in Time" Mixed Methods Process Evaluation Study. JMIR Res Protoc. 2022 Aug 19;11(8):e37634. doi: 10.2196/37634.'}]}, 'descriptionModule': {'briefSummary': 'The study will support implementation of a health promotive work-way in primary care setting by using external and internal facilitators, with the aim to identify effective implementation strategies and to evaluate intervention uptake. Data will be collected from multiple perspecitves.', 'detailedDescription': "Insufficient physical activity, hazardous use of alcohol, tobacco use and unhealthy eating habits increase the risk of cardiovascular diseases, cancer and type 2-diabetes. Health-promoting work reduces the disease risk and mortality and should thus be integrated in clinical care processes.\n\nDespite support by the National guideline for prevention and treatment of unhealthy life-style habits, there is a chasm to bridge when integrating evidence into clinical practise. Prerequisites for changing work-ways are often underestimated and left to the individual co-workers to full fill on their own.\n\nToo few patients are asked about life-style habits and too few receive evidence-based measures. The measures taken may also depend on sex, language, residence and caregiver's profession. The investigators strive to support the implementation of a health-promoting way of working that includes self-reporting of life-style habits before a visit and that takes measures for those with at least one unhealthy lifestyle habit.\n\nThe aim is to identify effective implementation strategies for health-promoting efforts in the primary care. The perceptions of barriers and opportunities when changing way of working from the target groups (leaders, co-workers, patients) will be used to enhance the possibility of successful implementation. Strategies are enhanced by theories of leading change. External and internal facilitators support the implementation.\n\nThe study will evaluate the effects and the implementation process at the level of leaders, patients, co-workers, facilitators and organisation in short (4-6 months) and long term (16-18 months).\n\nThe project provides generalizable knowledge on strategies to overcome the gap between evidence and praxis, contributing to utilize an existing synthesized knowledgebase regarding health-promoting and preventative workways in a Swedish primary care setting.\n\nIt is central for the health care system to identify successful implementation strategies in order to manage their future mission."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for co-workers:\n\n* being a caregiver meeting patients and/or\n* being assigned a role as internal or external facilitator in the project\n\nInclusion criteria for patients filling in the study specific questionnaire:\n\n* 18 years or older\n* visiting primary care units a specific time pre- or post implementation support\n\nInclusion criteria for personcentered processmapping:\n\n\\* : having one or more unhealthy life-style habit 18 years or older\n\nInclusion criterina for managers:\n\n\\* being a manager at a primary care unit or at higher level'}, 'identificationModule': {'nctId': 'NCT04799860', 'acronym': 'AcTi', 'briefTitle': 'Act in Time -Implementation of Health Promotive Work-way in Primary Care Setting (AcTi)', 'organization': {'class': 'OTHER', 'fullName': 'Region Örebro County'}, 'officialTitle': 'Act in Time- Implementation of Health Promotive Work-way in Primary Care Setting - Evaluation of Effect- and Implementation Process (AcTi)', 'orgStudyIdInfo': {'id': '275301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'health promotive work-way', 'description': 'Six primary care units that voluntarily enrolls as experimental units. The units will receive implementation support based on previous research and tailored to the specific prerequisits and context for each unit. Strategies includes involvement of target groups; informationa and interactive education;use of external and internal facilitators tarined for the purpose; systematic feedback and learning dialogs during the project. The implementation support will take approximately 12 months.', 'interventionNames': ['Behavioral: health promotive work-way']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Six primary care centers of similar size and socioeconomic background in the population listed to each center.'}], 'interventions': [{'name': 'health promotive work-way', 'type': 'BEHAVIORAL', 'description': 'Clinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken.\n\nImplementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations', 'armGroupLabels': ['health promotive work-way']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70185', 'city': 'Örebro', 'country': 'Sweden', 'facility': 'Region Örebro County', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Ylva Nilsagård', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Health Care Research Center, Region Örebro County'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "We don't collect individual data other than in the qualitative parts and we don't have ethical approval to share that"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Örebro County', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}