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(lightbulb) A how-to guide to design and develop your intervention protocol

Big picture things to consider:

Develop an event schedule for each arm of your study.  For each events these include:

  1. On what day should the event occur?

  2. At what time should the event start? 
  3. How long should the event window stay open? 
  4. Should the event repeat? If so, how many days, weeks? 
  5. Should there be consequences (i.e. messages, compliance, etc.) based on event outcome? 

Things to consider for each event type

  1. Send a Message 
    1. What day should the message be sent out?
    2. What time should the message be sent out? 
    3. What is the body of the message? 
    4. How should the message be sent out?
      1. Text only
      2. Email only
      3. Phone call only
      4. Per participant notification preference 
    5. Is this a one-time message or is it repeating?
      1. Repeating- by days or weeks? How many times should the message repeat? 

  2. Ask a question via text
    1. What day should the question be sent out?
    2. What time should the question be sent out? 
    3. What is the body of the question? 
    4. How long should the participant have to respond to the question?
    5. What are the valid responses that the participant should send? (e.g. 1, 2, 3) 
    6. What are the automated responses based on the participant's text? 
      1. What message should you send back for a response of 1? 2? 3?
      2. What message should you send back if the participant sends something other than a requested response (e.g. not 1-3)? 

    7. Is this a one-time question or is it repeating?

      1. Repeating- by days or weeks? How many times should the question repeat?

  3. Administer a survey 
    1. What day should the survey open? 
    2. What time should the survey open?
    3. What is the message that should be sent to the participant alerting to survey opening?
    4. How long should the participant have to respond to complete the survey?
    5. What should happen once the participant completes the survey?
      1. Message to participant
      2. Payment 
    6. Should there be a reminder to the participant to complete the survey if they don't fill it out?
      1. When should the reminders start?
      2. What time should the reminder be sent? 
      3. What is the body of the reminder message? 
      4. How often should the reminders occur? 

  4. Collect device (scale, pedometer, pill bottle, etc.) data 
    1. What day should the data collection start? 
    2. Should data collection repeat? ((lightbulb)Tip! Typically occurs daily)
      1. Repeating- by days or weeks? How many times should the data collection repeat?
    3. Should there be goals for the participant to meet?
      1. Example 1: participant walked more than 7000 steps --> met goal
      2. Example 2: participant weighed in under target weight --> met goal 

  5. Send a conditional message (a message sent based on a previous action taken by a participant) 
    1. What day should the conditional message be sent out?
    2. What time should the conditional message be sent out? 
    3. What is the body of the message? 
    4. What previous event is the message looking at to determine what to send? 
      1. Example: Evaluate pedometer data from previous day 
        1. Participant met their step goal yesterday --> send 'Congrats on reaching your step goal!'
        2. Participant did not meet their step goal yesterday --> send 'Try to meet your goal today!'
    5. How should the message be sent out?
      1. Text only
      2. Email only
      3. Phone call only
      4. Per participant notification preference 
    6. Is this a one-time message or is it repeating?
      1. Repeating- by days or weeks? How many times should the message repeat? 

  6. Run a lottery 
    1. What day should the lottery start?  
    2. What time should the lottery run?
    3. What should the lottery look at to determine if the participant is eligible? 
      1. Example: Evaluate if participant met their step goal the day before.  If yes --> eligible for winnings, if no --> ineligible for winnings 
    4. What are the price amounts?
      1. Matching 1 digit? 
      2. Matching 2 digits?
    5. What messages should be sent out to the participant for the 4 scenarios?
      1. (lightbulb) Tip! Include AMOUNT, YOUR_NUMBER, and WINNING_NUMBER variables to personalize 
      2. Eligible winner
      3. Eligible loser
      4. Ineligible winner
      5. Ineligible loser
    6. Should the lottery repeat? ((lightbulb)Tip! Typically occurs daily)
      1. Repeating- by days or weeks? How many times should the data lottery run?

  7. Apply gamification
    1. Should the participant gain or lose points for met/ unmet goals? 
      1. Example: daily medication adherence
        1. add 1 point to point balance for each day that the participant takes their medication
      2. Should the participant receive a message the next day about their medication adherence? Should the participant be told their running adherence score? 
    2. Should the participant move up or down levels for consistently met/ unmet goals? 
      1. Example: weekly medication adherence
        1. If participant has 5-7 points at the end of the week, move up a level
        2. If participant has 0-4 points at the end of the week, move down a level 
      2. Send the participant a message alerting to level 
    3. Should the point balance reset?
      1. Example: at the end of the week, set the medication adherence point balance to 0

(grey lightbulb) Want an example?! See below! 

1-month physical activity study with daily lottery incentive for meeting goal of >10,000 steps and text weekly check ins

  1. Welcome to study message
    • Start: Day 0
    • Time: As soon as the participant is started in the arm
    • Message:PARTICIPANT, welcome to the Fitbit study! Thank you for enrolling. 

  2. Daily step count from Fitbit
    • Start: Day 0
    • Time: As soon as the participant is started in the arm
    • Length of window: All day
    • Repeat: daily- every 1 day, 30 times 
    • Compliance: If participant walks > 10,000 steps, mark as meeting their goal

  3. Daily lottery 
    • Start: Day 1
    • Time: 11 am 
    • Repeat: daily- every 1 day, 30 times 
    • Feedback: if participant met their step count goal the previous day, then make them eligible for the lottery 
    • Message: 
      • eligible winner: You met your step goal yesterday and won AMOUNT in the lottery!
      • eligible loser: You met your step goal yesterday, but did not win the lottery this time.  Keep up the good work! 
      • ineligible winner: Had you met your step goal, you would have won AMOUNT in the lottery.
      • ineligible loser: Had you met your step goal, you would not have won the lottery this time. 

  4. Exercise tip #1 
    • Start: Day 3
    • Time: 9 am 
    • Message: Exercise tip #1: Use a buddy system! Find a friend or relative who also wants to establish a healthier lifestyle and keep each other accountable to goals. 

  5. Weekly check in text response 
    • Start: Day 7
    • Time: 10 am 
    • Message Prompt: Hi PARTICIPANT_FIRSTNAME, do you need help meeting your step goals? Text back yes or no. 
    • Length of participant response window: 10 am - 11:59 pm 
    • Repeat: weekly- every 1 week, 4 times 
    • Message:
      • if participant texts back 'no': 
        • participant: We are glad to hear that you are meeting your step goals! Keep up the great work! 
      • if participant texts back 'yes': 
        • participant: Thank you for your response. We will reach out to you for assistance within one business day. 
        • study team: Participant needs help meeting goals.  Reach out for assistance. 
      • if participant texts back invalid formatted text:
        • participant: We didn't understand your response, please text back 'yes' or 'no'.

  6. Mid point survey

    • Start: Day 15

    • Time: 11 am

    • Message Prompt: Hi PARTICIPANT, please click the following link to complete the mid-point survey! You have until END_DATE to complete the survey.  SURVEY_LINK

    • Amount of time participant has to complete survey:14 days 

    • Result of Survey Completion: if participant completes the survey, pay out $50 

       

  7. Mid point survey reminder

    • Start: Day 18

    • Time: 11 am 

    • Message: Please rememeber to log into the Fitbit study to complete your mid-point survey! 

    • Repeat: daily- every 2 days, 3 times 

    • Only send reminder to those who haven't completed the survey 

 

 

 

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