Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Pilot Study of Home Monitoring in Adults With Cystic Fibrosis (HOMECF)
Brief Summary: Cystic fibrosis (CF) is the most common fatal inherited condition in Caucasians, causing recurrent chest infections and premature death due to lung failure. When patients develop chest infections their symptoms usually slowly worsen over the course of several days to weeks. Due to this gradual onset, patients often seek medical attention several days or weeks after symptoms start to worsen. The Investigators believe that if they were able to monitor patients more closely they could diagnose and treat chest infections earlier and consequently improve health outcomes.

The HOMECF study aims to investigate whether home monitoring is beneficial for adults with CF. 100 subjects will be randomly allocated, 50 to receive home monitoring and 50 to receive routine clinical care for 12 months. Subjects receiving home monitoring will measure their lung function and symptoms twice weekly and this data will be transmitted to the medical team by means of a modified mobile phone.

the Investigators hypothesize that home monitoring will allow them to diagnose chest infections at an earlier stage and reduce hospital inpatient days. They will also assess the subjects' experience of receiving home monitoring, the impact on body weight and lung function and and conduct a full health economic analysis to assess value for money. They will also ask subjects to collect a urine sample once weekly to allow us to measure urinary levels of inflammatory markers.

Subjects will be recruited at the West Midlands Adult CF Centre in Birmingham. The research team are well placed to carry out the study because it is a large regional adult CF centre with an excellent record of conducting clinical research.


Options:
A: Arm Label: SMS and Internet; Type: EXPERIMENTAL; Interventions: Behavioral: MD2ME | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: MD2ME; Assigned to Arm(s): SMS and Internet
B: Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Home monitoring; Type: ACTIVE_COMPARATOR; Interventions: Device: Home lung function and symptom monitoring | Intervention Type: DEVICE; Name: Home lung function and symptom monitoring; Assigned to Arm(s): Home monitoring
C: Arm Label: Home monitoring; Type: EXPERIMENTAL; Interventions: Procedure: Home Monitoring | Arm Label: Clinical Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Clinical Care | Intervention Type: PROCEDURE; Name: Home Monitoring; Assigned to Arm(s): Home monitoring | Intervention Type: OTHER; Name: Clinical Care; Assigned to Arm(s): Clinical Care
D: Arm Label: Placebo (pooled two times a day [BID]/three times a day [TID]); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo two times a day (BID)/three times a day (TID) | Arm Label: AZLI (pooled two times a day [BID]/three times a day [TID]); Type: EXPERIMENTAL; Interventions: Drug: AZLI 75 mg two times a day (BID)/three times a day (TID) | Intervention Type: DRUG; Name: AZLI 75 mg two times a day (BID)/three times a day (TID); Assigned to Arm(s): AZLI (pooled two times a day [BID]/three times a day [TID]) | Intervention Type: DRUG; Name: Placebo two times a day (BID)/three times a day (TID); Assigned to Arm(s): Placebo (pooled two times a day [BID]/three times a day [TID])

Answer: C