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Quality of Life in Postmenopausal Women With Osteoporosis

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ClinicalTrials.gov Identifier: NCT03970902
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University Ghent

Brief Summary:

The researchers will evaluate the effectiveness of a complex intervention composed of multiple actions targeting primary care healthcare workers and postmenopausal women with osteoporosis by means of a quasi-experimental design in the form of a cluster-controlled trial with clustering at family physician level. The study has 2 study arms. In one arm, osteoporosis stakeholders receive a complex intervention (Integrated Osteoporosis Care). The second study arm serves as control and receives care as usual.

The complex intervention is composed of

  • education and provision of educational material for all stakeholders in primary osteoporosis care (patients, family physicians, nurse-educators, physiotherapists, dietitians, pharmacists and if present patient's informal caregivers)
  • patient self-management support by primary care osteoporosis stakeholders
  • the construction of a primary care osteoporosis treatment guideline and care pathway Effectiveness will be measured by questionnaires and data from the EMR and IMA-database, in patients, family physicians and informal caregivers.

Effects measured in family physicians are:

  • Identification failure rate
  • Percentage of family physicians correctly implementing the osteoporosis treatment guideline
  • Proportion of patients treated correctly as stated in the osteoporosis treatment guideline
  • Proportion of family physicians correctly registering osteoporosis related information in the EMR
  • Intensity of collaborative practices
  • Knowledge of osteoporosis management and treatment

Effects measured in patients are:

  • Medication Possession Ratio (Primary outcome)
  • Health literacy
  • Self-management efficacy
  • Self-reported treatment adherence
  • Self-reported nutritional intake
  • Intensity of integrated osteoporosis care
  • Patient satisfaction with integrated osteoporosis care
  • HRQoL
  • Functional independence (ADL)
  • Patient resource use

Effects measured in informal caregivers are:

  • HRQoL
  • QoL
  • Impact of caregiving The study elapse time is 18 months. Participating family physicians will receive postgraduate education and start to include patients during consultations in their doctor's office. The inclusion period is 6 months, patients eligible for participation are non-institutionalized postmenopausal women with a diagnosis of osteoporosis who are able to give informed consent.

The follow-up period for patients and family caregivers is 12 months. Follow-up period for family physicians is 18 months.


Condition or disease Intervention/treatment
Postmenopausal Osteoporosis Other: Integrated Osteoporosis Care Other: Care As Usual

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Effectiveness of an Integrated Osteoporosis Care Programme in Postmenopausal Women With Osteoporosis
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Group/Cohort Intervention/treatment
Integrated Osteoporosis Care
Group of formal and informal primary caregivers and non-institutionalized postmenopausal women with osteoporosis in whom a complex patient-tailored intervention is provided.
Other: Integrated Osteoporosis Care
Complex intervention in family physicians, primary caregivers, patients, informal caregivers. The intervention has a patient-tailored implementation. Family physicians: postgraduate education on osteoporosis management and integrated care, educational material. Primary care stakeholders (nurses, pharmacists, dietitians, physiotherapists): specialist training on patient-support in osteoporosis management with attention towards self-management support (nurses), treatment adherence and administration (pharmacists), fall risk, weight-bearing exercises, balance training and fear of falling (physiotherapists) and anti-inflammatory nutrition with sufficient calcium, vitamin D and protein intake (dietitians). Patients: patient-tailored complex intervention consisting of: education, support consultation(s)/telephones from an osteoporosis nurse, a pharmacist, a physiotherapist and nutritional a dietitian. Informal caregivers: education on supporting osteoporosis self-management.

Care As Usual
Group of formal and informal primary caregivers and non-institutionalized postmenopausal women with osteoporosis receiving care as usual for the management of osteoporosis.
Other: Care As Usual
No intervention Patients receive care as usual from their family physician




Primary Outcome Measures :
  1. Medication Possession Ratio (MPR) [ Time Frame: 12 months ]
    Medication Possession Ratio is the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period.


Secondary Outcome Measures :
  1. Identification Failure rate [ Time Frame: 18 months ]
    Percentage of women of where not offered DXA despite there eligibility based on risk factors, previous fragility fracture or clinical suspicion of a vertebral fracture

  2. Correct use of the osteoporosis treatment guideline [ Time Frame: 18 months ]
    Percentage of family physicians who implement the osteoporosis treatment guideline in the correct way in patients accepting treatment offered. This is defined as screening with DXA, treatment and follow-up as stated in the treatment guideline.

  3. Proportion of patients treated correctly [ Time Frame: 18 months ]
    The proportion of patients who where eligible for screening and/or treatment that were managed in the correct way as stated in the treatment protocol.

  4. Percentage of family physicians who correctly register osteoporosis management in the EMR [ Time Frame: 18 months ]
    The percentage of family physicians that correctly registers in the EMR the reimbursed fraction of the management and treatment of postmenopausal osteoporosis patients.

  5. Intensity of collaborative practices [ Time Frame: 18 months ]
    The proportion of patients that is referred to one or more professional caregivers for the management of postmenopausal osteoporosis.

  6. Knowledge of osteoporosis management and treatment [ Time Frame: 18 months ]
    Average score on an osteoporosis knowledge test

  7. Health-related competencies [ Time Frame: 12 months ]
    The proportion of patients that has sufficient health-literacy and self-management efficacy for osteoporosis management

  8. Self-reported treatment adherence [ Time Frame: 12 months ]
    The proportion of patients that reports that reports >80% treatment adherence for anti-osteoporotic medication

  9. Self-reported nutritional intake [ Time Frame: 12 months ]
    the proportion of patients that meets daily nutritional requirements as recommended by the healthy bone diet

  10. Self-reported medication intake [ Time Frame: 12 months ]
    The proportion of patients correctly reporting their osteoporosis medication, calcium and Vitamin D supplements

  11. Intensity of integrated osteoporosis care [ Time Frame: 12 months ]
    The proportion of patients that used one or more aspects of an integrative approach by consulting other caregivers and the intensity with which they did it.

  12. Patient satisfaction with osteoporosis care [ Time Frame: 12 months ]
    Proportion of patients that was satisfied with the care that was provided with the different caregivers they consulted for their osteoporosis care

  13. Patient Health Related Quality of Life (HRQoL) [ Time Frame: 12 months ]
    Evolution of HRQoL presented as QALY's

  14. Patient functional independence [ Time Frame: 12 months ]
    Evolution of functional independence expressed as activities of daily living (ADL) patients

  15. Resource use [ Time Frame: 12 months ]
    The identification of, duration of and frequency with which social and healthcare services used by patients

  16. Informal caregivers Health Related Quality of Life (HRQoL) [ Time Frame: 12 months ]
    Evolution of HRQoL presented as QALY's of the primary informal caregiver of the patient with postmenopausal osteoporosis

  17. Informal caregiver Quality of Life (QoL) [ Time Frame: 12 months ]
    Proportion of informal caregivers of patients with postmenopausal osteoporosis reporting a positive evolution in QoL

  18. Informal caregiver Impact of Caregiving [ Time Frame: 12 months ]
    Average time spent on caregiving and impact of caregiving on job performance and professional status



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participant eligibility is based on postmenopausal status
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Family physicians and their non-institutionalized postmenopausal patients with osteoporosis (yes or not newly diagnosed) who are able to give informed consent for participation within the study.
Criteria

Inclusion Criteria:

  • Patients Postmenopausal women with osteoporosis Non-institutionalized Able to give informed consent
  • Family physicians All family physicians willing to participate

Exclusion Criteria:

  • Patients Suffering from a terminal illness
  • Family physicians No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970902


Contacts
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Contact: Caroline Verdonck, MD +32478356043 caroline.verdonck@ugent.be
Contact: Liesbeth Borgermans, PhD

Locations
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Belgium
Family physician doctor's offices Recruiting
Ghent, Belgium, 9000
Contact: Caroline Verdonck, MD    +32478356043    caroline.verdonck@ugent.be   
Sponsors and Collaborators
University Ghent
Amgen
Investigators
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Study Chair: Liesbeth Borgermans, PhD University Ghent

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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03970902     History of Changes
Other Study ID Numbers: EC/2019/0578
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Ghent:
Integrated Care
Complex intervention
Primary care
Quality of Life

Additional relevant MeSH terms:
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Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases