Quality of Life in Postmenopausal Women With Osteoporosis

NCT03970902 | Completed DMC

• 1 other identifier: EC/2019/0578
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 1

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(IOC)). 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 (Electronic Medical Record)EMR and IMA-database, in patients and family physicians. 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(MPR) (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 (Activities of Daily Living - ADL)
• Patient resource use 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 is 12 months. Follow-up period for family physicians is 18 months.

Conditions

Postmenopausal Osteoporosis

Keywords

Integrated Care; Complex intervention; Primary care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Medication Possession Ratio (MPR)

  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.

  12 months

Secondary Outcomes (15)

• Identification Failure rate

  18 months

• Correct use of the osteoporosis treatment guideline

  18 months

• Proportion of patients treated correctly

  18 months

• Percentage of family physicians who correctly register osteoporosis management in the EMR

  18 months

• Intensity of collaborative practices

  18 months

Study Arms (2)

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

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

Interventions

Integrated Osteoporosis Care OTHER

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.

Integrated Osteoporosis Care

Care As Usual OTHER

No intervention Patients receive care as usual from their family physician

Care As Usual

Eligibility Criteria

• Gender Eligibility Details: Participant eligibility is based on postmenopausal status
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients Suffering from a terminal illness

Sponsors & Collaborators

• University Ghent: lead
• Amgen: collaborator

Study Sites (1)

Family physician doctor's offices

Ghent, 9000, Belgium

Location

Related Publications (1)

• Verdonck C, Annemans L, Goemaere S, Lapauw B, Goderis G, Balligand E, Doom MP, Perkisas S, Borgermans L. The effectiveness and cost-effectiveness of an integrated osteoporosis care programme for postmenopausal women in Flanders: study protocol of a quasi-experimental controlled design. Arch Osteoporos. 2020 Jul 22;15(1):107. doi: 10.1007/s11657-020-00776-7.

  PMID: 32700114 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Liesbeth Borgermans, PhD

  University Ghent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 3, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: April 1, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)