Multi-morbidity Signs and Symptoms Multi-morbidity
Conditions
Interventions
The trial has two arms: one intervention and one control arm.
In the control arm patients are treated as usual in accordance with the recommended standard.
In the int
Sponsors
Johann Wolfgang Goethe University (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. At least 60 years old of both sexes 2. At least three chronic diseases affecting two or more organ systems, which require pharmaceutical treatment 3. At least five long-term prescriptions with systemic effects 4. Health care provided by GP (at least one contact in most recent quarter) 5. Patient is legally competent to sign any documents 6. Ability to understand and participate in trial of own free will, to fill out questionnaires and participate in telephone interviews 7. Written informed consent to participate in trial Practices: 1. Practice serves members of the German statutory health insurance system 2. GP practice 3. Physician is specialised in general practice or internal medicine, or doctor with no specialist field 4. Internet access 5. Investigator's agreement to fulfil the contractual obligations arising from the trial 6. Investigator's agreement to the training of a health care assistant (HCA) from the practice for the intervention, as required by the trial
Exclusion criteria
Exclusion criteria: Patients: 1. Diseases cause life expectancy of less than 12 months 2. Abuse of alcohol or illegal drugs and visible clinical signs or symptoms thereof 3. Cognitive impairment that prevents trial participation (mini-mental state examination [MMSE] less than 26) 4. Emotional stress that prevents trial participation 5. Participation in a clinical trial within the last 30 days Practices: 1. Practice focuses on unconventional medical treatments 2. Practice focuses on special indications (e.g. human immunodeficiency virus [HIV])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in Medication Appropriateness Index (MAI) score 6 months from baseline minus baseline (MAI T1 - T0). There are three timepoints of data collection in both, the intervention and the control arm: T0: baseline, before randomisation and before beginning of the intervention T1: six months after baseline T2: nine months after baseline Data are collected via practice documentation (case report forms), patient questionnaire, and patient interview. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 02/11/2017: MAI T2 - T0 and the difference in the following scores 6 and 9 months from baseline minus baseline (T1 - T0 and T2 - T0): 1. Complexity of medication: Medication Regimen Complexity Index (MRCI), no. of prescriptions / single doses 2. Observed adherence: drug score, dose score, regimen score 3. Reported adherence: adherence according to Morisky 4. Patient attitude toward medication: Beliefs about Medicines Questionnaire (BMQ) 5. Generic health related quality of life (EQ-5D) 6. Functional disability: Vulnerably Elderly Survey ? 13 items (VES-13) 7. Pain assessment: grade of severity of chronic pain 8. All cause hospitalisation: hospital days 9. Satisfaction with shared decision making: Man-Sin-Hong scale (MSH) 10. Patient's future expectation, expected/desired lifetime duration: Years of Desired Life (YDL) 11. Cognitive dysfunction: Verbal Fluency Test (VFT) 12. Depression: Geriatric Depression Scale (GDS) There are three timepoints of data collection in both, the intervention and the control arm: T0: baseline, before randomisation and before beginning of the intervention T1: six months after baseline T2: nine months after baseline Data are collected via practice documentation (case report forms), patient questionnaire, and patient interview. Previous secondary outcome measures: MAI T2 - T0 and the difference in the following scores 6 and 9 months from baseline minus baseline (T1 - T0 and T2 - T0): 1. Complexity of medication: Medication Regimen Complexity Index (MRCI) 2. Observed adherence: drug score, dose score, regimen score 3. Reported adherence: | — |
Countries
Germany
Outcome results
None listed