Keesara MHealth Protocol #8

Keesara MHealth Protocol #8

by Sirina Keesara -
Number of replies: 2

1. Describe the study design you will employ in order to determine if your intervention has had an effect on the outcome variable of interest.

I will be conducting a randomized controlled trial as this is the highest standard to test any clinical intervention. My intervention is simple and implemented at the individual level so I do not need to engage multiple institutions or sites. I can randomize patients within the controlled setting of the clinic, but I will come across issues of contamination if patients talk to each other and show each other messages. 


2. Define the unit-of-analysis for your main outcome evaluation, the minimum meaningful effect size, and the sample size necessary to detect this effect size.

I will be looking at the patient level for the unit of analysis.  I have found a couple of stuides looking at interventions to promote continuation of family planning and other studies that look at mobile phone interventions to spread health education. I have found that the effect size that I expect is between 15-25%. This leads to a very wide spread for sample sizes, but to be conservation the number I need to enroll will be 150 per arm. 

In reply to Sirina Keesara

Re: Keesara MHealth Protocol #8

by Nicole Ling -

I agree with you Sirina, I think your project lends nicely to individual randomization to assess for outcome differences, and if you see them - it's great because you can argue strongly for causation by your intervention. What will your control be? A text message without any information about birth control?

In reply to Sirina Keesara

Re: Keesara MHealth Protocol #8

by Grace -

I was also wondering what your specific outcome would be. The reason I'm interested is that my protocol involves the use of health education but more at the provider level. I was just wondering how you would measure the effectiveness of the a mobile phone intervention.