Quality of Life in Postmenopausal Women With Osteoporosis

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

Interventions

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.

OTHER

Care As Usual

No intervention Patients receive care as usual from their family physician

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• University Ghent

  lead OTHER

Principal Investigators

• Liesbeth Borgermans, PhD · University Ghent

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-01

Primary Completion

2021-12-31

Completion

2022-04-01

Countries

• Belgium

Study Locations