Background Behind The PDE4B Accomplishments

If the patient does not meet the inclusion criteria, he or she is thanked for showing interest and the conversation is politely ended. Randomisation If a patient is eligible and willing to participate in the trial, he or she will be randomised to intervention plus usual care or usual care alone. Random allocation is conducted by using a system of sequentially numbered opaque sealed envelopes. Two employees, who are not involved in the research project or linked to the PI, place 33 notes stamped ��intervention group�� and 33 stamped ��control group�� in 66 identical envelopes. Subsequently, the envelopes are shuffled and numbered from 1 to 66. The envelopes are stored in a locked cabinet in a locked office in the central research unit. An independent co-worker from the research unit is given responsibility for randomisation and is instructed to keep the envelopes inaccessible to the research team. Participants are allocated to either the intervention or control group on a 1:1 basis. The PI contacts the independent co-worker by email and asks her to open the next envelope in line and report whether this patient is allocated to the intervention or control group. The independent co-worker marks the envelope with a patient ID, date and time to ensure and document that the envelopes are opened in the correct sequence. The PI informs the patients about whether they are randomised to the intervention or control group. Thus, the PI, patients and informal caregivers cannot influence patients�� assigned group. Patients are instructed to read and complete the consent form and the baseline questionnaires and return them by post (prepaid postage) or keep them until the PI's visit as part of the intervention. The time and place of the intervention is scheduled by the participant and the PI and optimally occurs within 1?week from randomisation. Follow-up For both groups, follow-up assessments will occur after 4?weeks (follow-up I) and 3?months (follow-up II) postintervention (figure 5). In the telephone booster session, the PI informs participants that they will receive the follow-up I questionnaire by mail within 4?weeks, and follow-up II questionnaire within 12?weeks. They are asked to complete and return the questionnaires within 1?week. If no Selisistat solubility dmso response is received within 2?weeks, the PI sends a reminder by mail and, as a last resort, contacts the patient by telephone. The purpose of contacting the patients by telephone is to encourage them to complete and return the questionnaires, or identify that they no longer want to participate in the trial. The recruitment process is estimated to last approximately 8�C10?months and will continue until 66 participants have been enrolled. Figure?5 Timeline chart.