Clinical trial NCT04382521: A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
Official title: A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipemia
Hypertension
Type2 Diabetes
Keywords: text message intervention
health behavior change
positive psychology
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized pilot trial to examine the feasibility, acceptability, and preliminary efficacy of an adaptive text message intervention (TMI) to promote well-being and health behavior adherence in 60 patients with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).

Detailed description: The investigators have developed an adaptive text message intervention (TMI) that uses participant feedback for individual messages and progress towards health goals to deliver increasingly personalized positive psychology (PP) and health behavior text messages over time. The investigators aim to examine its feasibility, acceptability, and preliminary efficacy in a randomized, controlled pilot trial in 60 adults with two or more cardiac risk conditions (hypertension, type 2 diabetes, or hyperlipidemia).

Eligibility criteria: Inclusion Criteria:

* Cardiac risk conditions. Participants will have two or more of hypertension, type-2 diabetes, and hyperlipidemia. Patients will have met 2+ of 2017 AHA-ACC criteria for hypertension (SBP ≥130, DBP ≥80), 2018 ADA criteria for type-2 diabetes (e.g., A1C ≥6.5%), and 2013 AHA-ACC criteria for hyperlipidemia (e.g., LDL cholesterol ≥190), via medical record review, with confirmation by healthcare providers as needed.
* Low physical activity or elevated sedentary leisure time (SLT). Low activity will be defined as ≤150 minutes/week of moderate to vigorous activity (MVPA), which is an ADA-recommended level of MVPA; elevated SLT will be ≥120 min/day, which is linked to adverse medical health. As initial screens for both MVPA and SLT, we will use the International Physical Activity Questionnaire (IPAQ). Patients reporting ≤150 min/week of MVPA or ≥120 min/day of SLT will wear accelerometers for 10 days to confirm low MVPA/high SLT (patients will indicate their leisure time hours to allow assessment of SLT during those hours).
* Suboptimal diet. Participants must also report either fewer than 5 daily servings of fruit/vegetables (measured by the Behavioral Risk Factor Surveillance System's \[BRFSS\] Fruit and Vegetable Consumption Module) or have a score of ≥70 on the MEDFICTS scale for fat/cholesterol intake, representing high risk. We will require diet and activity deficits to ensure that a broad range of messages will be relevant to every participant as we explore the utility of individual messages and patterns of message selection in this initial study.
* Ability to receive text messages. Participants must have a cellular phone that receives texts and that they use at least daily. We will remunerate them the cost of receiving the messages as needed.
* Ability to read in English or Spanish. Text messages will be available in English and Spanish.

Exclusion Criteria:

* Existing coronary artery disease (CAD; diagnosed via cardiac catheterization using standard coronary artery stenosis definitions or prior ACS).
* An unrelated condition limiting physical activity.
* Participation in programs focused on cardiac prevention or well-being (e.g., cardiac rehabilitation).
* A cognitive disturbance precluding participation or informed consent, assessed using a six-item screen designed to assess suitability for research participation.

Primary outcomes:
measure: Proportion of messages correctly delivered
timeFrame: 12 weeks
measure: Rates of feedback to individual text messages
timeFrame: 12 weeks
measure: Participant's mean ratings of message utility to measure acceptability of the text-message intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Positive and Negative Affect Schedule (PANAS) Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Life Orientation Test-Revised Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in General Self-Efficacy Scale score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in HADS-A Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in HADS-D Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Multidimensional Health Locus of Control Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Multidimensional Scale of Perceived Social Support Score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in MEDFICTS score
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Behavioral Risk Factor Surveillance System [BRFSS] Fruit and Vegetable Consumption Module
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in Moderate to vigorous physical activity (minutes) measured via accelerometer
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in physical activity (steps) measured via accelerometer
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in sedentary time measured via accelerometer
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in self-report physical activity time measured by International Physical Activity Questionnaire
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in physical function measured by PROMIS 20-item
timeFrame: Baseline, 12 weeks and 24 weeks
measure: Change in physical function measured by 6-minute test
timeFrame: Baseline, 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: