The effectiveness of hand-held digital multimedia presentation of trial information on recruitment and retention of patients to a trial in primary care: an embedded methodology trial protocol

The effect of a handheld digital multimedia information resource on recruitment and retention of patients to a trial in primary care

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12838042

Enrollment

460

Registered

2017-10-11

Start date

2017-09-11

Completion date

Unknown

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uncomplicated urinary tract infection Urological and Genital Diseases Urinary tract infection, site not specified

Interventions

Eligible patients will be identified by the General Practitioner (GP) within participating practices based on the inclusion and exclusion criteria outlined by SATIN. GPs will invite eligible patients

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: This SWAT will include healthy, non-pregnant, adult women presenting for consultation for a suspected uncomplicated UTI. The study population are individuals who are being screened for and/or who are eligible to take part in the host SATIN trial. To participate in SWAT-15 individuals must: 1. Be attending a general practice that is taking part in the SATIN trial 2. Have a GP-diagnosed UTI, and at least one of the symptoms dysuria, urinary frequency, or urgency with/without low abdominal pain 3. Be a woman (non-pregnant) aged 18 years or above 4. Be able and willing to give written informed consent 5. Own a smartphone

Exclusion criteria

Exclusion criteria: Key exclusion criteria are as per the SATIN host trial: 1. Any signs of complicated infection or any condition that may lead to complications 2. Current or recent antibiotic use 3. Recent UTI 4. Current intake of NSAIDs 5. Pregnancy or breastfeeding 6. Non-use of highly effective contraception 7. Previous adverse reaction to any of the study drugs 8. Current intake of drugs potentially interacting with the trial drugs 9. Diabetes mellitus, chronic kidney disease or any other previous illness related to kidney or urinary tract 10. History of gastro-intestinal ulcers, Glucose 6 phosphate Dehydrogenase deficiency or any other medical condition that may put the participant at risk or influence the study results in the investigators’ opinion

Design outcomes

Primary

Measure	Time frame
The proportion of potentially eligible participants willing to participate in the SATIN trial, calculated as the number of participants who sign the SATIN informed consent form, Measured at 1 year or when trial recruitment has closed	—

Secondary

Measure	Time frame
1. The proportion of participants recruited to the SATIN trial (in case this differs from the number of participants willing to participate, due to e.g. exclusion criteria), recorded in the SATIN electronic case report form (eCRF), measured at 1 year or when trial recruitment has closed 2. The proportion of recruited participants who are retained to the end of the SATIN trial. Retention will be measured as the number of participants who complete the UTI Symptom Score (see SATIN protocol) on days 0-7 and until day 14 or until recovery is achieved, whichever occurs first. Measured at 1 year or when trial recruitment has closed 3. The quality of decision-making, measured through the completion of a decisional scale 2 days after viewing the recruitment material. The scale is adapted from one used within the REFORM trial and drawing conceptually on the SURE and DelibeRATE scales	—

Measure

Time frame

1. The proportion of participants recruited to the SATIN trial (in case this differs from the number of participants willing to participate, due to e.g. exclusion criteria), recorded in the SATIN electronic case report form (eCRF), measured at 1 year or when trial recruitment has closed 2. The proportion of recruited participants who are retained to the end of the SATIN trial. Retention will be measured as the number of participants who complete the UTI Symptom Score (see SATIN protocol) on days 0-7 and until day 14 or until recovery is achieved, whichever occurs first. Measured at 1 year or when trial recruitment has closed 3. The quality of decision-making, measured through the completion of a decisional scale 2 days after viewing the recruitment material. The scale is adapted from one used within the REFORM trial and drawing conceptually on the SURE and DelibeRATE scales

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Countries

Ireland

Contacts

Public ContactDeclan Devane

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026