Tailored interventions to improve adherence to medication in elderly patients with Parkinson’s disease: a randomized controlled trial
Organizational Data
- DRKS-ID:
- DRKS00023655
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2021-02-24
- Last update in DRKS:
- 2023-03-22
- Registration type:
- Prospective
Acronym/abbreviation of the study
AdhCare
URL of the study
No Entry
Brief summary in lay language
Many people are unable or unwilling to take their medication as agreed with their treating physician. This so-called non-adherence causes high costs, is associated with poorer health, increased hospital treatment and poorer quality of life. Among others, three broad patterns of non-adherence can be described: 1) patients modify their prescribed medications without consulting physician (e.g., reduce the dose), 2) patients have poor knowledge about their medication, and 3) patients forget to take their medications. With this randomized controlled intervention study, we aim to specifically address these patterns of non-adherence in elderly non-adherent patients. To do so, we compare patients with Parkinson´s disease who receive an intervention adapted to the patterns of non-adherence (AdhCare arm) with patients who do not receive an intervention (control arm). We want to test if such an intervention leads to better medication adherence and thus better mobility and body function after 6 months.
Brief summary in scientific language
The aim of the study is to evaluate the effectiveness of an individualized intervention to enhance adherence in terms of motor function in older people with Parkinson's disease. It is based on the NeuGerAdh study (DRKS00016774), a longitudinal observational study of adherence in elderly patients with neurological disorders. Already in previous studies we were able to show that non-adherence has different reasons or patterns: (1) modifications of medication without consulting physician, (2) lack of knowledge about the prescribed medication, and (3) forgetting to take the medication. We will conduct a randomized controlled trial to test the effectiveness of AdhCare. AdhCare is an individualized intervention to improve adherence, tailored to each patient's reason for non-adherence. The primary endpoint of the study is motor function assessed with the combined MDS-UPDRS II and III (revised Unified Parkinson's Disease Rating Scale) after 6 months in the control vs. AdhCare arm (Intent-To-Treat). Secondary outcomes are self-reported adherence, pill count, and number of physician visits. We will also qualitatively assess perceptions of the intervention as well as barriers and facilitators to implementation.
Health condition or problem studied
- Free text:
- Non-Adherence
- ICD10:
- G20 - Parkinson disease
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- AdhCare: All patients in this group receive a tailored intervention to improve adherence depending on the individual reasons of non-adherence: - Standardized informational talk to improve patient empowerment to take responsibility and control of their own health. - Written summary of the most important aspects for their individual improvement of adherence. - Their physician, who continues treatment, will be contacted and informed about the study and the individual patient’s adherence-problems and barriers and possible strategies to minimize non-adherence in the individual patient. - A follow-up telephone call with the patient to reinforce the respective focus about the medications and adherence.
- Arm 2:
- Control: All patients in this group will receive standard information about the course and therapy of the Parkinson’s disease. In the form of: - An informative conversation - Written-down information (leaflet) - Follow-up telephone call about course of disease and possible therapies.
Endpoints
- Primary outcome:
- The primary endpoint in this study is motor function assessed with the combined MDS-UPDRS II and MDS-UPDRS III (revised Unified Parkinson's Disease Rating) after 6 months in the control vs. AdhCare arm (Intent-To-Treat).
- Secondary outcome:
- Self-reported adherence (SAMS), Medication adherence scores, Number of Primary Care Visits. We will also qualitatively evaluate the perception of intervention and barriers and facilitators for the implementation. Will be assessed after 3 and 6 month.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Caregiver
- Data analyst
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Department of Neurology Jena
Recruitment period and number of participants
- Planned study start date:
- 2021-04-01
- Actual study start date:
- 2021-04-26
- Planned study completion date:
- 2023-09-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 128
- Final Sample Size:
- 132
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 60 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- - The patient is clinically diagnosed with Parkinson‘s disease according to the MDS-criteria - Montreal cognitive assessment (MoCA) ≥ 19/30 points - Patient manages his medication independently - Presence of self-reported non-adherence according to the German Stendal Adherence with Medication Score (SAMS > 1) - Informed consent is obtained from the participant
Exclusion Criteria
- Acute psychotic symptoms, delirium - Montral cognitive assessment (MoCA) < 19/30 - Patient is not actively involved in drug management (e.g., bedridden in nursing home) - Inability to provide informed consent
Addresses
Primary Sponsor
- Address:
- Department of Neurology, Jena University HospitalPD Dr. Tino PrellAm Klinikum 107747 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Department of Neurology, Jena University HospitalPD Dr. Tino PrellAm Klinikum 107747 JenaGermany
- Telephone:
- +49 3641 9 323497
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Department of Neurology, Jena University HospitalDr. Hannah MühlhammerAm Klinikum 107747 JenaGermany
- Telephone:
- +49 3641 9 323546
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Department of Neurology, Jena University HospitalPD Dr. Tino PrellAm Klinikum 107747 JenaGermany
- Telephone:
- +49 3641 9 323497
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesministerium für Bildung und Forschung Dienstsitz BerlinFriedrichstraße 130 B10117 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.bmbf.de
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Interdisziplinäres Zentrum für Klinische Studien (IZKF)Salvador-Allende-Platz 2907747 JenaGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen FakultätBachstr. 18 Gebäude 107740 JenaGermany
- Telephone:
- +49-3641-9391191
- Fax:
- +49-3641-9391192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-01-26
- Ethics committee number:
- 2021-2091-BO
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-02-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- All of the individual participant’s data that underlie the results after deidentification will be placed on a corresponding platform, beginning immediately following article publication. Data can be used for scientific purpose. In addition the study protocol will be published.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry