NCT00567294

Brief Summary

Osteoporosis is a common bone disease in older adults in which the bones become weaker and prone to fracture. Medications are available to slow or even stop disease progression. However, very few adults who are prescribed osteoporosis medications actually follow through with filling their prescriptions and taking the medications. Ways to improve medication use have not been well developed or adequately tested. The purpose of this study is to evaluate a telephone coaching program, with or without helpful adherence notifications to doctors, in improving treatment adherence in older adults who are starting an osteoporosis medication.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,087

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

2.1 years

First QC Date

November 30, 2007

Last Update Submit

May 14, 2012

Conditions

Osteoporosis

Keywords

OsteoporosisMedication adherenceTelephonic educationMotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • Medication adherence

    At Month 12

Secondary Outcomes (1)

  • Medication persistence

    At Month 12

Study Arms (3)

A

ACTIVE COMPARATOR

Participants will receive mailed education materials on osteoporosis and medication use.

Behavioral: Mailed education

B

EXPERIMENTAL

Participants will receive a telephone coaching program.

Behavioral: Telephone coaching program for patients

C

EXPERIMENTAL

Participants will receive a telephone coaching program, and doctors of these participants will receive medication adherence alert notifications.

Behavioral: Telephone coaching program for patientsBehavioral: Medication adherence alert program for doctors

Interventions

Mailed educationBEHAVIORAL

Mailed education materials on osteoporosis and medication use over a 1-year period

A
Telephone coaching program for patientsBEHAVIORAL

A telephone coaching program that will involve twelve monthly 5- to 10-minute phone calls from a health educator who is specially trained in osteoporosis. The phone calls will involve coaching participants on behavioral reinforcement strategies that will help them to continue taking their medications on schedule; phone calls will also include specially tailored education on osteoporosis and fracture prevention. A close family member or friend of the participant will also be contacted via phone two times during the study by the health educator. During these phone calls, the family member or friend will learn how to support the participant in such a way that medication adherence is more likely.

BC
Medication adherence alert program for doctorsBEHAVIORAL

Doctors of participants will receive written educational information on the rates of medication adherence, implications of nonadherence, and methods for improving adherence among people with osteoporosis. Doctors will also receive alerts on any patients who are not filling their medication prescriptions.

C

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients enrolled in the Pharmaceutical Assistance Contract for the Elderly (PACE) program at the Pennsylvania Department of Aging who begin taking a medication for osteoporosis

You may not qualify if:

  • Unable to communicate over the telephone with health educators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • Solomon DH, Iversen MD, Avorn J, Gleeson T, Brookhart MA, Patrick AR, Rekedal L, Shrank WH, Lii J, Losina E, Katz JN. Osteoporosis telephonic intervention to improve medication regimen adherence: a large, pragmatic, randomized controlled trial. Arch Intern Med. 2012 Mar 26;172(6):477-83. doi: 10.1001/archinternmed.2011.1977. Epub 2012 Feb 27.

    PMID: 22371876RESULT

MeSH Terms

Conditions

OsteoporosisMedication Adherence

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Daniel H. Solomon, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Timothy Gleeson, BS

    Brigham and Women's Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

January 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

US(1)