Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2026-01-09 @ 3:00 PM
Study NCT ID:
NCT04461561
Status:
UNKNOWN
Last Update Posted:
2020-07-27
First Post:
2020-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009472', 'term': 'Neuronal Ceroid-Lipofuscinoses'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-24', 'studyFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2020-07-07', 'lastUpdatePostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.", 'timeFrame': '2 weeks after the end of WBT course', 'description': 'The data collection instrument is NoMAD \\[1\\]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory \\[2\\], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from "Not at all" to "Completely". The items in part C are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to \'Agree Strongly\'. \'Neutral\' and \'Not applicable\'.'}, {'measure': "The NoMAD Instrument, to describe respondents' experiences of using the intervention in the workplace.", 'timeFrame': 'at 3 months for both groups', 'description': 'The data collection instrument is NoMAD \\[1\\]. The NoMAD translated into Arabic for the purpose of evaluating the normalization of the pediatric palliative care provide by web-based training concept. The Arabic-NoMAD is divided into 3 sections. It begins with section A consisting of 12 questions about the respondent, section B with 3 general questions about the intervention. Section C contains 20 specific questions about the intervention, corresponding to the 4 constructs of the normalization process theory \\[2\\], with Coherence and Cognitive Participation has 4 items, 7 items for Collective Action, and 5 items for Reflexive Monitoring. The scale consists of 31 Likert-type items. Items in section B are answered with a 10-point Likert scale ranging from "Not at all" to "Completely". The items in part C are answered using a 5-point Likert scale, ranging from "Disagree Strongly" to \'Agree Strongly\'. \'Neutral\' and \'Not applicable\'.'}], 'secondaryOutcomes': [{'measure': 'The interview, using framework analysis, informed by normalization process theory toolkit', 'timeFrame': 'For 3-months post-course', 'description': 'Semi-structured face-to-face interviews will be conducted by all nurses on how successful passing ELNEC-PPC WBT course from the selected setting. All participants had direct contact with patients. Three rounds of interviews will be conducted after 3 months. After consenting, participants will be interviewed by the main researcher (MA). All interviews will be audio-recorded and transcribed. They will be asked why they felt the change was significant. During the second round of interviews, will be asked about the most significant developments since the beginning of the program; they will be asked to share their views about pediatric palliative care and to describe the extent to which they were adopting the approach, and if not, why not. Topic guides were informed by NPT \\[3\\], it will be used the interactive NPT toolkit. It contains 16 questions, for thinking through an implementation problem. The work was embedding improved and edited statements and explanations into a web-enabled tool.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['life-limiting illnesses', 'pediatric palliative care', 'normalization process theory', 'End-of-life care', 'Web-Based Training Intervention'], 'conditions': ['Cancer', 'Cardiac Anomaly', 'Cystic Fibrosis', 'Muscular Dystrophy', 'HIV/AIDS', "Batten's Disease", 'Cerebral Palsy']}, 'referencesModule': {'references': [{'pmid': '30442093', 'type': 'BACKGROUND', 'citation': 'Rapley T, Girling M, Mair FS, Murray E, Treweek S, McColl E, Steen IN, May CR, Finch TL. Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018 Nov 15;18(1):133. doi: 10.1186/s12874-018-0590-y.'}, {'pmid': '22568958', 'type': 'BACKGROUND', 'citation': 'Rifkin LH, Stojadinovic S, Stewart CH, Song KH, Maxted MC, Bell MH, Kashefi NS, Speiser MP, Saint-Cyr M, Story MD, Rohrich RJ, Brown SA, Solberg TD. An athymic rat model of cutaneous radiation injury designed to study human tissue-based wound therapy. Radiat Oncol. 2012 May 8;7:68. doi: 10.1186/1748-717X-7-68.'}, {'pmid': '21961827', 'type': 'BACKGROUND', 'citation': 'May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, Treweek S, Rapley T. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011 Sep 30;11:245. doi: 10.1186/1472-6963-11-245.'}, {'pmid': '36367759', 'type': 'DERIVED', 'citation': 'Al-Shammari MA, Yasir A, Aldoori N, Mohammad H. Using Normalization Process Theory to Evaluate an End-of-Life Pediatric Palliative Care Web-Based Training Program for Nurses: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Nov 11;11(11):e23783. doi: 10.2196/23783.'}], 'seeAlsoLinks': [{'url': 'http://www.normalizationprocess.org/npt-toolkit/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to explain the provision of palliative care at the end of life by the implementation of the ELNEC course, as WBT Program using the Normalization Process Theory, that focus attention on how complex interventions become routinely embedded in practice. In addition to, identify the changes implemented by the participant nurses (intervention group) in their clinical practice, after participating in WBT Program to provide Palliative Care alongside with usual care versus usual care only (control group) for children with life-limiting conditions or in the case of accidents/sudden death, at the end of life. And finally, provide findings that will assist in the interpretation of the trial results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The health care centers where the intervention will be administered include 1) Imam Sadiq (peace be upon him) Teaching Hospital; 2) Babylon Maternity and Children Teaching Hospital; 3) Al-Noor Hospital for Children; 4) Morgan Teaching Hospital, and 5) Babylon Oncology Center.\n* The study population will be included all college nurses who completed their bachelor's degree and who have (master's or doctorate) degree in nursing sciences, that being employed for at least three months and not expected to be transferred to another unit within the study period during either morning or evening shifts and provides nursing care for both male and/or female of hospitalized patients 18 years.\n* Use a computer (desktop or laptop) with access to the internet at home or work (phone line or internet access), or use a smartphone (with at least Android 6.0+ or iOS11. 0+) with internet access (Wi-Fi and/or mobile data) to join the online training course.\n* Have a working email address and/or a working mobile number and have access to a computer or smartphone with internet access to complete questionnaires in a web browser.\n\nExclusion Criteria:\n\n* Not interested.\n* Not being employed for at least three months.\n* Academic nurses who employed and continuing to work with other than selecting units, due to the carefully chosen only units that provide nursing care for both pediatric and adults or for pediatric, in order to achieve the study objectives.\n* Enrolled in another experimental trial."}, 'identificationModule': {'nctId': 'NCT04461561', 'acronym': 'ELNEC-PPC', 'briefTitle': 'Using NPT to Evaluate Providing PPC as ELNEC-PPC WBT for Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Altoosi University College'}, 'officialTitle': 'Using Normalization Process Theory to Evaluate Providing Pediatric Palliative Care at End-of-Life as Web-Based Training Intervention for Nurses:', 'orgStudyIdInfo': {'id': 'AltoosiUC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ELNEC-PPC WBT pluss usual care', 'description': 'The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website', 'interventionNames': ['Genetic: end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care only', 'description': 'Participants nurses deliver usual care as his/her role appropriate to neonates, infants, toddlers, preschoolers, school age, also to adolescents in selected unit of perinatal, neonatal, and settings which can be pediatric.'}], 'interventions': [{'name': 'end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care', 'type': 'GENETIC', 'otherNames': ['ELNEC-PPC WBT course plus usual care'], 'description': 'The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website', 'armGroupLabels': ['ELNEC-PPC WBT pluss usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hillah', 'state': 'Babylon Province', 'status': 'RECRUITING', 'country': 'Iraq', 'contacts': [{'name': 'Moustafa Al-Shammari, Master', 'role': 'CONTACT', 'email': 'Mustafa.ali@altoosi.edu.iq', 'phone': '07816706378'}, {'name': 'Moustafa A Al-Shammari, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': '1) Imam Sadiq (peace be upon him) Teaching Hospital; 2) Babylon Maternity and Children Teaching Hospital; 3) Al-Noor Hospital for Children; 4) Morgan Teaching Hospital; and 5) Babylon Oncology Center', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}], 'centralContacts': [{'name': 'Moustafa Ali G Al-Shammari, Master', 'role': 'CONTACT', 'email': 'Mustafa.ali@altoosi.edu.iq', 'phone': '07816706378'}], 'overallOfficials': [{'name': 'Nuhad Aldoori, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Babylon University/ Nursing Faculty'}, {'name': 'Amean A Yaser, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Babylon University/ Nursing Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altoosi University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Babylon University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Moustafa Ali Ghazi Al-Shammari', 'investigatorAffiliation': 'Altoosi University College'}}}}