An interventional study of Optimization strategy (complex intervention) in Chronic Disease, sponsored by Goethe University. Completed at 1 site in Germany. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2017-10-31.
Sponsored by Goethe University · Not applicable, Interventional, and Treatment
Objective: To investigate whether the complex intervention will improve the appropriateness of prescriptions in elderly multi-morbid patients with multi-medication in general practices.
Study hypothesis: The primary objective of the study is to determine whether the complex intervention will improve the appropriateness of prescriptions compared to usual care. The primary efficacy endpoint is the change in the Medication Appropriateness Index (MAI) score from baseline (T0) to 6 months after baseline (T1), i.e. the difference MAI T1-T0.
Key elements (1 to 4) of the complex intervention:
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's enrollment of 505 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →Goethe University is the lead sponsor of 97 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Intervention: Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Other: Optimization strategy (complex intervention)
Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard# #Recommended standard: clinical practice guideline "Geriatrie" of the guideline group of Hesse (part 1 and 2)
Also known as: Intervention arm
Medication Appropriateness Index (MAI)-Score
Difference in Medication Appropriateness Index (MAI)-Score 6 months from baseline minus baseline (MAI T1-T0)
Time frame: 6 months from baseline
MAI-Score
Difference in Medication Appropriateness Index (MAI)-Score 9 months from baseline minus baseline (MAI T1-T0)
Time frame: 9 months from baseline
Generic health related quality of life: EQ-5D
Change in generic health related quality of life measured as the difference in the EQ-5D-Score 6 months from baseline minus baseline (T1-T0)
Time frame: 6 months from baseline
Generic health related quality of life: EQ-5D
Change in generic health related quality of life measured as the difference in the EQ-5D-Score 9 months from baseline minus baseline (T2-T0)
Time frame: 9 months
Functional disability: Vulnerable Elderly Survey (VES-13)
Change in functional disability measured as the difference in the VES-13-Score 6 months from baseline minus baseline (T1-T0)
Time frame: 6 months
Functional disability: Vulnerable Elderly Survey (VES-13)
Change in functional disability measured as the difference in the VES-13-Score 9 months from baseline minus baseline (T2-T0)
Time frame: 9 months
Change in all cause hospitalisation
Time frame: 6 months and 9 months
"Observed" adherence
Change in observed adherence measured as the difference between intake (patient's interview) and prescribed medication (CRF reported by physician's) 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 months from baseline and 9 months from baseline
Self-reported adherence (Morisky)
Change in self-reported adherence measured as the difference in the Morisky-Score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Future life expectancy / years of desired life
Change in perceived future life expectancy reflects concepts of will to life or years of desired life \[YDL\] measured as the difference of the three items future expectation / expected lifetime duration / desired lifetime duration in the interval 6 months
Time frame: 6 and 9 months from baseline
medication complexity
Change in complexity of medication measured as the difference 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0) * Total number of prescriptions * Number of single doses / day * Medication Regimen Complexity Index (MRCI)
Time frame: 6 and 9 months from baseline
Beliefs about Medicines Questionaire (BMQ)
Change in health and illness beliefs and attitudes measured as the difference in the Beliefs about Medicines Questionaire (BMQ) score 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Severity of chronic pain
Change in severity of chronic pain measured as the difference in Characteristic Pain Intensity score, the Disability Score, in Disability Points and the resulting Grades of chronic pain severity in accordance with M. von Korff, J. Ormel et al. the interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Satisfaction with shared decision making (Man Son Hing scale, MSH)
Change in satisfaction with shared decision making measured as the difference in the Man Son Hing scale (MSH) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Cognitive dysfunction in verbal fluency
Change in cognitive (dys)function measured as the difference in the Verbal Fluency Test (VFT) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Depressive symptoms
Change in depressive symptoms measured as the difference in the Geriatric Depression Scale (GDS) interval 6 months from baseline minus baseline (T1-T0) and 9 months from baseline minus baseline (T2-T0)
Time frame: 6 and 9 months from baseline
Plan to share: No
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