Improving Compliance Among Elderly Polypharmacy Users Thr... | NCT00916214

Studies
Improving Compliance Among Elderly Polypharmacy Users Through Community Pharmacy Based Pharmaceutical Care Program

NCT00916214

Sponsor

Ringkobing Love Apotek

Status

Completed

Last Update Posted

Jun 14, 2011Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Polypharmacy

Interventions

Pharmaceutical care program

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Jun 2011Actual

First Submitted Date

Jun 1, 2009

First Submission Date that Met QC Criteria

Jun 8, 2009

First Posted Date

Jun 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2011

Last Update Posted Date

Jun 14, 2011Estimated

Name	Class
Ministry of Health and Prevention	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the project is to evaluate effectiveness of a multidimensional pharmaceutical care plan in improving compliance among elderly polypharmacy users at community pharmacy settings. The specific objective of the project is to determine effects of pharmaceutical care program on medication adherence and persistence among elderly polypharmacy users.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental		Other: Pharmaceutical care program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmaceutical care program	Other	The pharmaceutical care program consists of 2 elements, that includes individualized medication education and regular follow up	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in medication adherence from run-in to the end of phase 1		6 months
persistence of mean medication adherence		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both men and woman aged more than 65 years and taking more than 2 drugs

Exclusion Criteria:

Inhabitants of nursing homes
People receiving unit dose dispensing of medicine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad Saeed	Ringkøbing apotek	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ringkøbing Løve Apotek		Ringkøbing		6950	Denmark