Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The objective of this observational study is to collect and evaluate data on medication adherence of patients on maintenance COPD therapy with long-acting anticholinergic (e.g. Spiriva® delivered by HandiHaler® or Respimat®) using the MMAS-8 questionnaire.
Detailed description
Purpose:
Interventions
PROCEDUREEducation
Education
Sponsors
Pfizer
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female ambulatory outpatients being seen in a participating physicians office for routine care, * Patients with a clinical diagnosis of COPD and already being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium (Spiriva® HandiHaler® or Respimat®) at least 1 month and within product label * Patient fluent in language of questionnaire and having the cognitive and functional abilities required to fill in the questionnaire alone
Exclusion criteria
* Uncooperative patients as judged by the physician * Patients with any conditions excluded as per Country specific package insert * Patients currently enrolled in any clinical trial which requires a change in medication for their respiratory problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline | Baseline and 6 months | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months. | 6 months and 12 months | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence. |
| Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline | 12 months and baseline | The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence. |
Countries
Hungary, Slovakia, Slovenia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With COPD Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label. | 1,253 |
| Total | 1,253 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 16 |
| Overall Study | Lost to Follow-up | 30 |
| Overall Study | Others than specified above | 13 |
Baseline characteristics
| Characteristic | Patients With COPD |
|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 9.95 |
| Sex: Female, Male Female | 480 Participants |
| Sex: Female, Male Male | 773 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,253 |
| serious Total, serious adverse events | 59 / 1,253 |
Outcome results
Primary
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 3 minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
Time frame: Baseline and 6 months
Population: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With COPD | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Educational Period After 6 Months From Baseline | 0.6 units on a scale | Standard Deviation 1.84 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 1 (baseline). Therefore, a positive change score reflects an improvement in the adherence.
Time frame: 12 months and baseline
Population: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results both at baseline and after 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With COPD | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From Baseline | 0.7 units on a scale | Standard Deviation 1.82 |
p-value: <0.0001t-test, 2 sided
Secondary
Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months.
The MMAS-8 scale is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score on visit 4 minus the score at visit 3. Therefore, a positive change score reflects an improvement in the adherence.
Time frame: 6 months and 12 months
Population: This patient set includes all patients in the TS who have valid MMAS-8 questionnaire results after 6 and 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With COPD | Mean Change of Morisky Medication Adherence Scale -8 (MMAS-8) Score at the End of the Observational Period After 12 Months From End of Educational Period After 6 Months. | 0.2 units on a scale | Standard Deviation 1.46 |
p-value: 0.0002t-test, 2 sided