PARTICIPANT DIARY TREATMENT ALLOCATION: LACTIC ACID GEL

Transcription

1 PARTICIPANT DIARY TREATMENT ALLOCATION: LACTIC ACID GEL For site staff completion only: Participating Site: Participant Initials: Participant ID: Date of Randomisation: Allocated Treatment: Lactic Acid Gel; 5ml tube once daily

2 INSTRUCTIONS This patient diary is intended to help you keep a record of your Bacterial Vaginosis (BV) treatment and symptoms over the next 6 months. Please use this diary so that you can be as accurate as possible when you fill in the online questionnaires, which will tell us how well the treatments are working. In particular, it would be very useful if you noted: How much of your study treatment you take If you have any side effects from the study treatment When your BV resolves (clears) If your BV returns and when If you have used any other treatments for your BV If you have contact with any other health services for your BV (e.g. saw your GP, pharmacist etc.) You do not have to complete your diary (and we do not need you to send it back to us) but we have found that it usually helps to have something to refer back to when you complete the online questionnaires. A link to the online questionnaires will be sent to you by 2 weeks (14 days) after joining the study, and then again at 3 months and at 6 months. On the day we send you the link for each questionnaire we will also send you a text notification. A text reminder will be sent 5 days and 10 days after the due date if you have not completed your questionnaire. Thank you for your invaluable contribution to the VITA trial! How to use your lactic acid gel Using your lactic acid gel: For 7 days, you will be using one single use tube of lactic acid gel per day. The lactic acid gel should be inserted intravaginally before bedtime. Missed doses: If you accidentally forget to use one of the tubes, you should not use two tubes of your lactic acid gel on the same day but insert the lactic acid gel as scheduled the following day. Insert trial / emergency contact details vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 2 of 16

3 STUDY TREATMENT (Week 1) Record the brand of lactic acid gel you are using: Balance Activ Relactagel Canesbalance Other please specify: Record the date you start using your lactic acid gel and note each time you use the gel over the next 7 days below: Date you start using your lactic acid gel: D D M M M Y Y Y Y Day Tube of lactic acid gel used? Day 1 Yes No Day 2 Yes No Day 3 Yes No Day 4 Yes No Day 5 Yes No Day 6 Yes No Day 7 Yes No Space for additional days if required (if any doses missed day 1-7): Day 8 Yes No If you stopped using your lactic acid gel what was the reason? I accidentally missed taking the gel I didn t like taking the gel Side effects of the gel (If side effects, please note in the side effects section) other please specify: vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 3 of 16

4 WEEK 2 You will now have completed your 7 day course of lactic acid gel. In another 7 days we will send you an online questionnaire to complete. This will be called your week 2 questionnaire as it will then be (approximately) 2 weeks since the start of your BV treatment. To help you complete your week 2 questionnaire, keep a note of the following: BV SYMPTOMS How are your BV symptoms 2 weeks after starting your lactic acid gel? Cleared/disappeared date that symptoms cleared: D D M M M Y Y Y Y Better, but not cleared/disappeared Improved initially, but worsened again No change Worse If you still have BV symptoms at the end of week 2 do they include? A genital discharge which you think is not normal: Yes An offensive vaginal smell (a smell that is unpleasant to you): Yes Irritation inside or around the vagina (including itching, pain or burning): Yes vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 4 of 16

5 SIDE EFFECTS STUDY TREATMENT In the two weeks since starting your lactic acid gel, please note if you experience any of the following (it would also be helpful to note how many hours/days after starting to use the lactic acid gel that any side effects started: Nausea: Yes If yes, how long after starting your study treatment did your nausea start? If yes, how severe was your nausea? Able to eat normally Ability to eat and drink fluids significantly decreased Unable to eat or drink fluids If yes, approximately how long did your nausea last (hours/days)? Vomiting: Yes If yes, how long after starting study treatment did your vomiting start? If yes, how many episodes in 24 hours? 1 episode in 24 hours 2 5 episodes in 24 hours 6 or more episodes in 24 hours or need IV fluids If yes, approximately how long did your vomiting last (hours/days)? Change in taste / abnormal taste: Yes If yes, how long after starting study treatment did your change in taste/abnormal taste occur? If yes, how severe was the change in your taste? Mild Moderate Severe If yes, approximately how long did your change in taste/abnormal taste last (hours/days)?? Vaginal irritation (may include itching/pain/burning sensation): Yes If yes, how long after starting study treatment did any vaginal irritation occur? If yes, how severe was your vaginal irritation? Mild Moderate Severe If yes, approximately how long did your vaginal irritation last (hours/days)? Abdominal pain: Yes If yes, how long after starting study treatment did any abdominal pain occur? If yes, how severe was your abdominal pain? Mild Moderate Severe If yes, approximately how long did your abdominal pain last (hours/days)? Diarrhoea: Yes If yes, how long after starting study treatment did any diarrhoea start? If yes, how severe was your diarrhoea? Mild Moderate Severe If yes, approximately how long did your diarrhoea last (hours/days)? vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 5 of 16

6 ADDITIONAL MEDICATIONS FOR YOUR BV In addition to your lactic acid gel, have you taken any of the following medications in the two weeks since joining the study? (Either prescribed to you by a doctor or bought over-the-counter e.g. bought separately in a pharmacy or online): Metronidazole tablets: Yes If yes, prescribed to you by a doctor? Yes If yes, number of courses taken: Metronidazole vaginal gel: Yes If yes, prescribed to you by a doctor? Yes If yes, number of courses taken: Additional Lactic acid vaginal gel (e.g. Relactagel, Balance Activ or Canesbalance ): Yes If yes, prescribed to you by a doctor? Yes If yes, number of courses taken: Clindamycin cream (e.g. Dalacin): Yes If yes, prescribed to you by a doctor? Yes If yes, number of courses taken: Other treatment for BV: Yes If yes, please specify: If yes, prescribed to you by a doctor? Yes If yes, number of courses taken: Have you received any antibiotics for any other condition/illness since starting the lactic acid gel? Yes If yes, please specify: Was this antibiotic(s) prescribed? Number of courses taken? Amoxicillin Yes Flucloxacillin Yes Doxycycline Yes Other Yes Please specify: Have you developed any vaginal thrush since starting the lactic acid gel? Yes If yes, specify treatment taken: Was this treatment prescribed? Number of courses taken? Clotrimazole (e.g. Canesten) Yes Fluconazole (e.g. Diflucan) Yes Itraconazole (e.g. Sporanox) Yes Other Yes Please specify: No treatment taken vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 6 of 16

7 SEXUAL CONTACT Have you had sex since starting study treatment? Yes If yes, how many days after starting study treatment did you first have sex? If yes, did you use condoms? Yes If yes, did you use condoms: Always (including oral sex) Not for oral sex but otherwise always Sometimes. Have you had any new sexual partners since starting study treatment? Yes vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 7 of 16

8 USE OF HEALTH SERVICES FOR YOUR BV Please note how many face-to-face or telephone consultations you have had with each of the following NHS services since you started the study treatment. Only include those consultations that are related to your bacterial vaginosis or treatment: (please do not record the original visit where you were first prescribed your treatment) NHS SERVICE Service used? *If YES, service used provide details: Face-to-face contact (please record the number of times) Telephone contact (please record the number of calls) GP appointment Yes* Nurse (GP surgery) appointment Yes* Specialist sexual health clinic appointment (e.g. GUM clinic) Yes* NHS outpatient appointment (other than a specialist sexual health clinic/gum clinic) Yes* NHS walk in centre Yes* NHS 111 Yes* GP out of hours service Yes* Pharmacy Yes* A & E Department Yes* Other Please specify: Yes* In the two weeks since starting your lactic acid gel, have you been to any hospital for an overnight stay because of problems related to your bacterial vaginosis? Yes If yes, NHS or private hospital? NHS hospital Private hospital If yes, number of nights you stayed in hospital: If yes, the reason for your stay(s) in hospital: vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 8 of 16

9 In the two weeks since starting your lactic acid gel, have you been to any hospital for an overnight stay because of side effects linked to your study treatment? Yes If yes, NHS or private hospital? NHS hospital Private hospital If yes, number of nights you stayed in hospital: If yes, the reason for your stay(s) in hospital: WEEK 2 VAGINAL SAMPLES Please note when you use your week 2 sample kit to take your week 2 samples (vaginal swabs and microscopy slide). These samples should be taken as instructed in your kit leaflet approximately 14 days from randomisation. D D M M M Y Y Y Y Date that you take your week 2 vaginal samples: (This should be 2 weeks (14 days) from when you started your study treatment) Date that you post your week 2 vaginal samples: (This should be within a few days of you taking your samples) D D M M M Y Y Y Y END OF WEEK 2 QUESTIONS vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 9 of 16

10 WEEK 3-3 MONTHS Over the next 3 months please keep a record of answers to the questions below in your diary. At the end of these 3 months we will send you an online questionnaire to complete. This will be called your 3 Month questionnaire as it will now be (approximately) 3 months since the start of your BV treatment. To help you complete your 3 month questionnaire, keep a record of the following: BV SYMPTOMS Had your BV symptoms cleared by the end of week 2 (when you completed the week 2 questionnaire)? Yes If no, please write down the date they subsequently cleared: (With or without additional treatment) D D M M M Y Y Y Y Over the next 3 months please make a note in this table if you have any recurrence of BV (note each new episode): Recurrence of BV symptoms? Date symptoms started? Between week 3 3 Months How long? (number of days) Name of treatment (if any taken) vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 10 of 16

11 Over the next 3 months please make a note in this table each time when you develop vaginal thrush, or any take antibiotics: Symptoms of vaginal thrush? Yes Between week 3 3 Months If yes, enter the date(s) that each episode of vaginal thrush started? Any antibiotics taken for any other condition / illness? Yes If yes, name of antibiotic? Was this antibiotic prescribed? SEXUAL CONTACT Have you had sex since completing your week 2 questionnaire? Yes If yes, how many days after starting study treatment did you first have sex? If yes, did you use condoms? Yes If yes, did you use condoms: Always (including oral sex) Not for oral sex but otherwise always Sometimes. Have you had any new sexual partners since completing your week 2 questionnaire? Yes vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 11 of 16

12 USE OF HEALTH SERVICES FOR YOUR BV Please note how many face-to-face or telephone consultations you have had with each of the following NHS services since you started the study treatment. Only include those consultations that are related to your bacterial vaginosis or treatment: (please do not record the original visit where you were first prescribed your treatment, or any contacts you have already included in your week 2 questionnaire) NHS SERVICE Service used? *If YES, service used provide details: Face-to-face contact (please record the number of times) Telephone contact (please record the number of calls) GP appointment Yes* Nurse (GP surgery) appointment Yes* Specialist sexual health clinic appointment (e.g. GUM clinic) Yes* NHS outpatient appointment (other than a specialist sexual health clinic/gum clinic) Yes* NHS walk in centre Yes* NHS 111 Yes* GP out of hours service Yes* Pharmacy Yes* A & E Department Yes* Other Please specify: Yes* Since completing your week 2 questionnaire, have you been to any hospital for an overnight stay because of problems related to your bacterial vaginosis? Yes If yes, NHS or private hospital? NHS hospital Private hospital If yes, number of nights you stayed in hospital: If yes, the reason for your stay(s) in hospital: END OF 3 MONTH QUESTIONS vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 12 of 16

13 3 6 MONTHS Over the remaining 3 months please keep a record of answers to the questions below in your diary. At the end of these 3 months we will send you an online questionnaire to complete. This will be called your 6 Month questionnaire as it will now be (approximately) 6 Months since the start of your BV treatment. This will be your final questionnaire. To help you complete your 6 month questionnaire, keep a record below. BV SYMPTOMS Had your original BV symptoms, at the beginning of the study, cleared by the end of 3 months (when you completed the 3 month questionnaire)? Yes If no, please write down the date if they subsequently cleared: (With or without additional treatment) D D M M M Y Y Y Y Please make a note in this table if you have any recurrence of BV between 3-6 months after being given the study treatment (note each new episode): Recurrence of BV symptoms? Date symptoms started? Between 3 Months 6 Months How long? (number of days) Name of treatment (if any taken) vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 13 of 16

14 Between the next 3-6 months please make a note in this table each time when you develop vaginal thrush, or any take antibiotics: Between 3 Months 6 Months Symptoms of vaginal thrush? Yes If yes, enter the date(s) that each episode of vaginal thrush started? Any antibiotics taken for any other condition / illness? Yes If yes, name of antibiotic? Was this antibiotic prescribed? Y/N SEXUAL CONTACT Have you had sex since completing your 3 month questionnaire? Yes If yes, how many days after starting study treatment did you first have sex? If yes, did you use condoms? Yes If yes, did you use condoms: Always (including oral sex) Not for oral sex but otherwise always Sometimes. Have you had any new sexual partners since completing your 3 month questionnaire? Yes vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 14 of 16

15 USE OF HEALTH SERVICES FOR YOUR BV Please note how many face-to-face or telephone consultations you have had with each of the following NHS services since you started the study treatment. Only include those consultations that are related to your bacterial vaginosis or treatment: (please do not record the original visit where you were first prescribed your treatment, or any contacts you have already included in your week 2 and 3 month questionnaire) NHS SERVICE Service used? *If YES, service used provide details: Face-to-face contact (please record the number of times) Telephone contact (please record the number of calls) GP appointment Yes* Nurse (GP surgery) appointment Yes* Specialist sexual health clinic appointment (e.g. GUM clinic) Yes* NHS outpatient appointment (other than a specialist sexual health clinic/gum clinic) Yes* NHS walk in centre Yes* NHS 111 Yes* GP out of hours service Yes* Pharmacy Yes* A & E Department Yes* Other Please specify: Yes* Since completing your 3 month questionnaire, have you been to an NHS hospital for an overnight stay because of problems related to your bacterial vaginosis? Yes If yes, NHS or private hospital? NHS hospital Private hospital If yes, number of nights you stayed in hospital: If yes, the reason for your stay(s) in hospital: END OF 6 MONTH QUESTIONS vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 15 of 16

16 Additional space for you to use for notes if you wish: vita Patient Diary_Lactic Acid_Final Version 1.0, 29-Jun-2017 Page 16 of 16