Medication Adherence Enhancement in Heart Transplant Reci... | NCT00843960

Studies
Medication Adherence Enhancement in Heart Transplant Recipients

NCT00843960

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Oct 7, 2009Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Medication Adherence
Self Management
Rejection

Interventions

behavioral adaptation and symptom management

Countries

Germany

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

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2010Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Feb 12, 2009

First Submission Date that Met QC Criteria

Feb 12, 2009

First Posted Date

Feb 13, 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

Oct 6, 2009

Last Update Posted Date

Oct 7, 2009Estimated

Name	Class
German Federal Ministry of Education and Research	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	intervention group	Behavioral: behavioral adaptation and symptom management
2	No Intervention	control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
behavioral adaptation and symptom management	Behavioral	behavioral adaptation and symptom management	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of adverse events (composite endpoint)		at month 60

Secondary Outcomes

Measure	Description	Time Frame
Adherence behavior measurement variables from MEMS system		first 3 month
Immunosuppression level		Month 3, 12 and 60
All individual components of the composite endpoint occurence of adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all eligible patients with follow-up at our outpatient clinic
written informed consent
sufficient German language skills to read and answer a battery of questionnaires
> 18 years
minimum 6 mts post HTX

Exclusion Criteria:

illiteracy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christiane Kugler, PhD	Contact	++49.511.532	6586	kugler.christiane@mh-hannover.de

Overall Officials

Name	Affiliation	Role
Christiane Kugler, PhD	Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Recruiting	Hanover		30625	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36094829	Derived	Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

ID	Term
D055118	Medication Adherence
D012059	Rejection, Psychology

ID	Term
D010349	Patient Compliance
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services