Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT04931602
Status:
UNKNOWN
Last Update Posted:
2022-04-19
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining Feasibility of a Model of Care for Secondary Fracture Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D006620', 'term': 'Hip Fractures'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005264', 'term': 'Femoral Fractures'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015502', 'term': 'Absorptiometry, Photon'}], 'ancestors': [{'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 172}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-18', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Secondary fracture prevention of hip', 'timeFrame': '1 year of follow-up', 'description': 'Rate of Secondary fracture of hip (occurrence of hip fracture (n) if any during the follow up will be noted)'}, {'measure': 'Total Secondary fracture prevention', 'timeFrame': '1 year of follow-up', 'description': 'Rate of total fracture (occurrence of fracture (n), if any, during the follow up will be noted)'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of the models of care- Follow up plan', 'timeFrame': '1 year of follow-up', 'description': "On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for follow-up was explained to the participant clearly"}, {'measure': 'Effectiveness of the models of care- Care provided post fracture', 'timeFrame': '1 year of follow-up', 'description': "On a Likert's scale of 1 to 5, rating will be recorded from the participants for: Participant is satisfied with the care provided post fracture."}, {'measure': 'Effectiveness of the models of care- Adequacy of information provided', 'timeFrame': '1 year of follow-up', 'description': "On a Likert's scale of 1 to 5, rating will be recorded from the participants for: right amount of information was given to the participant for secondary fracture prevention"}, {'measure': 'Effectiveness of the models of care- Communication', 'timeFrame': '1 year of follow-up', 'description': "On a Likert's scale of 1 to 5, rating will be recorded from the participants for: The plan for managements for secondary fracture prevention was communicated adequately"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip fractures', 'fracture', 'prevention'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': "Osteoporosis is a disorder of low bone mass and micro-architectural deterioration resulting in decreased mechanical strength and increased susceptibility to fractures even after minimal trauma. These 'minimal trauma fractures' (also known as 'osteoporotic', 'low trauma' or 'fragility' fractures) are the hallmark of a chronic and disabling disease that affects both men and women worldwide. On statistical grounds, more than 50 % of postmenopausal women and 30 % of men over the age of 60 years will suffer at least one minimal trauma fracture during their remaining lifetime. Any osteoporotic fracture predisposes to further fractures, significant morbidity and premature death. Thus, following a first minimal trauma fracture both men and women have a two- to threefold increased risk of subsequent fracture.\n\nThis study aims to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \\& D model as proposed by Ganda et al at the Aga Khan University, with collaboration of the departments of Orthopaedics, Chemical Pathology, Family Medicine and Internal Medicine.", 'detailedDescription': "With the severity of implications associated with fragility fractures, prevention of a secondary fracture has become a primary focus from a patient care and societal standpoint worldwide. However, this area has been so far neglected in Pakistan. A fracture requires that two conditions occur simultaneously: week bones and a fall or stress on week bones and a co-management approach is required to address both issues.\n\nThe investigators propose to determine feasibility of evaluating different models of care through a structured multidisciplinary path tailored to identify, assess and treat hip fracture patients in an effective timely manner that are at high risk of subsequent fracture (Type A model) and to compare its effectiveness and feasibility with a type B, C \\& D model as proposed by Ganda et al. Based on this study the investigators will propose a model of care for SFP for application at national level in private and public sector. The long-term plan is to develop a national fragility fracture network in preventing and managing fragility fractures and to promote research aimed at better treatments of osteoporosis, sarcopenia and fracture in line with global CtA from FFN. This information will also help us in applying clinical practice guidelines for osteoporosis and driving policy change for our country which is currently non-existent and is likely to be a step towards the achievement of Sustainable Development Goals (SDG) (i.e. ensure healthy lives and promote wellbeing for all at all ages) and in line with WHO decade of healthy ageing 2021-23.\n\nSpecific Aims:\n\nThis study is primarily aimed at comparison of the feasibility and effectiveness of models of care (Type A, B, C \\& D) for hip fracture patients. The Specific, Measurable, Achievable, Realistic, and Time-defined (SMART) goals of this project are formulated around the 5IQ approach delineated by the Royal Osteoporosis society based on the following 6 parameters.\n\nI. Identification: systematic screening of high-risk individuals\n\nII. Investigation: undertaking of relevant investigations to delineate the cause of low bone mass\n\nIII. Information: educating patients on falls prevention and fracture risk\n\nIV. Initiation: provision of pharmacological, lifestyle, dietary, conservative management approach and falls prevention interventions according to the model of care adopted\n\nV. Integration: promotion of integration between primary and secondary care\n\nVI. Quality: Ensuring professional development, audit, and peer-review activities\n\nType A model: Intensive service with all routine interventions:\n\nParticipants will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.\n\nComprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form.\n\nType B model: All intervention except treatment initiation-the responsibility of participants general practitioner for prevention of secondary fracture Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Participants will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \\&/or non-compliance will be filled by the coordinator.\n\nType C model: Health education only provided at the time of admission with handover to family physician for follow-up. Participants will be given an appointment to follow-up at community health center of Aga Khan University.\n\nType D model: Health Education provided. There is no physician contact with the participant's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to the participant along with counselling by the nurse at the time of discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with low trauma hip fractures at the out-patients or at emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women ≥50 years with low trauma hip fracture\n* All post-menopausal women ( less than 50 years) with low trauma hip fracture\n* Men ≥50 years with low trauma hip fracture\n\nExclusion Criteria:\n\n• Patients with high impact hip fracture including after road traffic accident'}, 'identificationModule': {'nctId': 'NCT04931602', 'briefTitle': 'Determining Feasibility of a Model of Care for Secondary Fracture Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Determining Feasibility of a Model of Care for Secondary Fracture Prevention for Implementation in Health Care System in Pakistan After Hip Fracture: a Clinical Outcome Study', 'orgStudyIdInfo': {'id': '2020-3409-14191'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Model A', 'description': 'Patients will be followed-up at bone, endocrine and rheumatology clinic after discharge depending upon availability of the consultant. Multifaceted risk-factor assessment for identifying patients at risk will be conducted including formal future fracture risk assessment/life style/medication review and fall risk assessment.\n\nComprehensive laboratory designed package including calcium (Ca), albumin (ALB), phosphate (P), bone alkaline phosphatase (BAP), C terminal peptide of type 1 collagen (CTx), vitamin D (25OHD) and intact parathyroid hormone (iPTH) will be performed at first clinic visit for all patients between 6-8 weeks post fracture. Screening for secondary causes of osteoporosis will be conducted for those identified in need. BMD testing as per guidelines for patients with fragility fractures will be conducted at clinic visit and recorded with risk assessment form (12).', 'interventionNames': ['Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan']}, {'label': 'Model B', 'description': "All routine intervention except treatment initiation-the responsibility of patient's general practitioner for prevention of secondary fracture. Those included in this intervention arm, will be identified and risk assessment will be performed at hospital admission. Recommendations for the treatment will be made to be initiated by the patient's general physician. Patients will be followed at 6 months on telephone, and a questionnaire related to treatment compliance \\&/or non-compliance will be filled by the coordinator.", 'interventionNames': ['Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan']}, {'label': 'Model C', 'description': 'Health education only provided at the time of admission with handover to family physician for follow-up. Patients will be given an appointment to follow-up at community health center of Aga Khan University', 'interventionNames': ['Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan']}, {'label': 'Model D', 'description': "Health Education provided. There is no physician contact with the person's general practitioner for prevention of secondary fracture. Education material for the patient have been prepared and will be provided to patient along with counselling by the nurse at the time of discharge", 'interventionNames': ['Diagnostic Test: Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan']}], 'interventions': [{'name': 'Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'investigations for secondary causes of osteoporosis', 'armGroupLabels': ['Model A', 'Model B', 'Model C', 'Model D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sibtain Ahmed', 'role': 'CONTACT', 'email': 'sibtain.ahmed@aku.edu', 'phone': '02134861951'}], 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Sibtain Ahmed', 'role': 'CONTACT', 'email': 'sibtain.ahmed@aku.edu', 'phone': '+922134861951', 'phoneExt': '1951'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sibtain Ahmed', 'investigatorAffiliation': 'Aga Khan University'}}}}