Table 5.
Analysis of Pilot and Feasibility trial protocols
| Pilot and feasibility trial protocols with a retention strategy (n = 41, 40.2%) | ||
|---|---|---|
| ORRCA Domain | Number of protocols (%) | Examples of quotes from the protocols |
| Data collection | ||
| A3. Data collection location and method | 2 (4.9%) | Patients who have consented to participate receive a questionnaire and pre-paid addressed envelope |
| B. Participants | ||
| B1. Reminders (including repeat contacting of participants via phone, post, email) | 3 protocols (7.3%) |
Reminder Patients who were allocated to Fatigue Information Sheet only, will be asked about their experience of reading the Fatigue Information Sheet. A postal reminder will be sent to non-responders 2 and 4 weeks after the 7-day response period has ended, utilising the Reminder Letter and/or a telephone call. Six and 12 months post randomisation, two more outcome booklets will be sent respectively, with two postal reminders and/or telephone calls for non-responders after 2 and 4 weeks |
| Prompts | 2 protocols (4.9%) |
Prompt All clinical outcomes, except for limb circumference, will be collected via self-report questionnaires. Reminder emails and/or calls will be sent out by the Research Assistant prior to each follow-up assessment at week 5 and week 11 |
| B2. Monetary incentives – direct cash provided to participants/gift vouchers, prizes that are monetary | 9 protocols (22%) | Participants in both arms will receive a modest monetary compensation of $30CAD each time they meet with the research assistant for data collection every 3 months for an expected time of 1 h (five times total). This amount is seen as a token of appreciation yet non-coercive |
| Conditional incentives | ||
| B3. Non-monetary incentives—entry to raffles for prizes that are non-monetary, completion of trial certificates, offering the controls the intervention at the end of the trial | 1 protocol (2.4%) | To prevent attrition, condensed WheelSeeU training or iWheel information is offered to all participants at the end of the study |
| Unconditional incentives | ||
| B4. Maintaining participant engagement | 1 protocol (2.4%) | All reasonable efforts, within the CRF local standard operating procedure, will be made to ensure optimum participant engagement and to reduce study attrition |
| B7. Supporting participation | 1 protocol (2.4%) | The follow-up appointment will be arranged during the baseline meeting, at a time convenient to participants, and will take place in a clinic at the hospital |
| B8. Contact information | 2 protocol (4.9%) | Participants are asked to give their own details as well as those of a family member or friend in case it is difficult to contact them directly |
| C. Sites and site staff | ||
| C6. Trial site factors | 1 protocol (2.4%) | The intention of conducting the study within the neighbourhood of the participant is to facilitate the transferability of training and to improve the ecological validity. In addition, training in the community aims to reduce participant burden of travelling to our research site, and to improve adherence |
| Combined strategies | 19 protocols (46.3%) | |
| Top most common combined retention strategies; | ||
|
• Monetary incentives – conditional • Prompt |
2 (10.5%) | Study participants will be contacted at 3 months by a study researcher to confirm contact details and as a reminder about the 6-month assessment. A follow-up interview will then be scheduled for 6 months after randomisation. All participants will be offered a £20 honorarium following completion of the 6-month follow-up interview |
|
• Monetary incentives – conditional incentive • Supporting participation • Data collection location and method |
2 (10.5%) | Women from both trial groups will be asked to attend an appointment with a research midwife to be weighed either at the study site or at their home at 6 and 12 months. Travel costs and £10 Love2Shop voucher to thank women for their time will be offered. Follow-up appointments will be offered at weekends and week days, with the option to complete questionnaires at these appointments |
|
• Data collection location and method • Reminder |
2 (10.5%) | The follow-up questionnaires are posted to participants with a reply paid envelope. The protocol for following up questionnaires begins with a 2-week waiting period (from postage date) and four phone calls over 7 days if it is not received within this time. Should phone contact be unsuccessful, research staff contact the recruiting site to check the situation of the patient (e.g. patient death). If the patient’s situation has changed, research staff review carer’s eligibility in collaboration with clinical staff at the site. If the patient’s situation is unchanged, a replacement questionnaire is sent and the same waiting period and phone call schedule are followed. Participants are withdrawn if contact is not made after this second waiting period |