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Exemplar: Determining the Best Practices for EMA Studies

Not Applicable
Completed
Conditions
Ecological Momentary Assessment Best Practices
Interventions
Behavioral: Ecologial Momentary Assessment settings
Registration Number
NCT05194228
Lead Sponsor
University of Oklahoma
Brief Summary

Ecological momentary assessment (EMA) is a measurement methodology that utilizes the repeated collection of real-time data on participants' behavior and experience in their natural environment. While EMA allows researchers to gain valuable insights into dynamic behavioral processes, the need for frequent self-report can be burdensome and disruptive to participants. Compliance with EMA protocols is important for accurate, unbiased sampling, yet there is no "gold standard" for EMA study design. In the present study, the investigators aim to use a factorial design to identify the optimal components, or combinations of components, for achieving the highest compliance rates for smartphone-based ecological momentary assessments (EMAs). Participants will be randomized into 1 of 32 conditions in a 2x2x2x2x2 design (i.e., number of questions per EMA survey \[15 vs. 25\] x number of EMAs per day \[2 vs. 4\] x EMA prompting schedule \[random vs. fixed times\]) x payment type \[per EMA vs. based on percentage of EMAs completed\] x order of EMA item question types \[i.e., slider type first 2 weeks vs. Likert-type questions first 2 weeks\]). All participants will complete EMAs for 4 weeks. The effect of each factor on EMA compliance will be examined, as well as the effects of interactions on EMA compliance. The investigators will also examine within and between-subjects factors that influence response rates, and 2) contextual features such as environment and mood that may be associated with better compliance and participant engagement. The results of this study will have broad applications for developing best practices guidelines for future studies utilizing EMA methodologies.

Detailed Description

Ecological momentary assessment (EMA) is a measurement methodology that utilizes the repeated collection of real-time data on participants' behavior and experience in their natural environment. EMA has been used in behavioral science for years, including research examining the environmental and psychological antecedents of cigarette smoking, substance use disorders, anxiety, eating, and sleep. EMA sampling strategies are typically time-based or event-based. Time-based sampling is solicited based on a schedule; for example, a daily diary prompted every day at the same time, or at random intervals (e.g., every 3-4 hours) each day. In contrast, event- based sampling is centered around a pre-defined event and is typically initiated by the participant. For example, a participant may be asked to initiate an assessment every time the participant smokes a cigarette.

Several studies have examined the impact of EMA study design features on participant compliance. In a recent meta-analysis of compliance with EMA protocols among substance users, there was no evidence that compliance rates were associated with prompt frequency, length of assessment period, or reimbursement. Another study using a pooled dataset of 10 EMA studies found that compliance declined across days, and varied significantly depending on the time of day. In a meta-analysis of EMA studies in mental health research, a higher number of EMAs per day were associated with lower compliance, however the number of days was not. While these studies provide preliminary guidance regarding EMA study design, their results are unfortunately inconsistent, and the varied reporting across studies with respect to the definition of compliance, study design elements, and study populations make it difficult to clearly derive best practice guidelines for EMA design.

In the present study, the investigators use a factorial design to identify the optimal components, or combinations of components, for achieving the highest compliance rates for smartphone-based ecological momentary assessments (EMAs). In addition, the investigators will explore the association between EMA design features and participant compliance/response rates. A factorial design is ideal for exploring these research questions because it is statistically more efficient, as this type of design needs fewer participants to answer questions about each experimental factor of interest.6 In this study, participants will be randomized into 1 of 32 conditions (i.e., number of questions per EMA survey x number of EMAs per day x EMA prompting schedule x EMA item type x payment type) to explore:

1. both within and between-subjects factors that influence response rates, and

2. contextual features such as environment and mood that may be associated with better compliance and participant engagement. The results of this study will have broad applications for developing best practice guidelines for future studies utilizing EMA methodologies.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
416
Inclusion Criteria
  • At least 18 years of age
  • Demonstrate > 6th grade English literacy level
  • Possess an active Android smartphone that is compatible with the Insight (TM) platform with a data plan and an operating system version 6.0 or higher
  • Agree to install the study smartphone application onto their personal phone
  • Agree to complete EMAs prompted by and completed through the study smartphone application
Read More
Exclusion Criteria
  • Under 18 years of age
  • Demonstrates < 6th grade English literacy level
  • Does not possess an active Android smartphone that is compatible with the Insight (TM) platform with a data plan and an operating system version 6.0 or higher
  • Does not agree to install the study smartphone application onto their personal phone
  • Does not agree to complete EMAs prompted by and completed through the study smartphone application
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Group 26Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 15 questions per EMA Fixed schedule Likert first
Group 2Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 15 questions per EMA Fixed schedule Likert first
Group 4Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 15 questions per EMA Random schedule Likert first
Group 17Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 15 questions per EMA Fixed schedule Slider first
Group 19Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 15 questions per EMA Random schedule Slider first
Group 31Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 25 questions per EMA Random schedule Slider first
Group 7Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 25 questions per EMA Random schedule Slider first
Group 9Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 15 questions per EMA Fixed schedule Slider first
Group 10Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 15 questions per EMA Fixed schedule Likert first
Group 16Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 25 questions per EMA Random schedule Likert first
Group 14Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 25 questions per EMA Fixed schedule Likert first
Group 22Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 25 questions per EMA Fixed schedule Likert first
Group 23Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 25 questions per EMA Random schedule Slider first
Group 6Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 25 questions per EMA Fixed schedule Likert first
Group 13Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 25 questions per EMA Fixed schedule Slider first
Group 21Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 25 questions per EMA Fixed schedule Slider first
Group 24Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 25 questions per EMA Random schedule Likert first
Group 27Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 15 questions per EMA Random schedule Slider first
Group 28Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 15 questions per EMA Random schedule Likert first
Group 30Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 25 questions per EMA Fixed schedule Likert first
Group 1Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 15 questions per EMA Fixed schedule Slider first
Group 3Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 15 questions per EMA Random schedule Slider first
Group 5Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 25 questions per EMA Fixed schedule Slider first
Group 11Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 15 questions per EMA Random schedule Slider first
Group 12Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 15 questions per EMA Random schedule Likert first
Group 18Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 15 questions per EMA Fixed schedule Likert first
Group 20Ecologial Momentary Assessment settingsPayment by % EMAs 2 EMAs per day 15 questions per EMA Random schedule Likert first
Group 25Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 15 questions per EMA Fixed schedule Slider first
Group 8Ecologial Momentary Assessment settings$1 Payment per EMA 2 EMAs per day 25 questions per EMA Random schedule Likert first
Group 15Ecologial Momentary Assessment settings$1 Payment per EMA 4 EMAs per day 25 questions per EMA Random schedule Slider first
Group 29Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 25 questions per EMA Fixed schedule Slider first
Group 32Ecologial Momentary Assessment settingsPayment by % EMAs 4 EMAs per day 25 questions per EMA Random schedule Likert first
Primary Outcome Measures
NameTimeMethod
Proportion of assigned daily smartphone surveys that are completed.through study completion for each participant, 28 days

Proportion of daily smartphone surveys completed will vary based upon group assignment.

Secondary Outcome Measures
NameTimeMethod
Number of minutes required to complete the smartphone-based surveys.through study completion for each participant, 28 days

Time to complete smartphone based surveys will vary based upon group assignment.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center

🇺🇸

Oklahoma City, Oklahoma, United States

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