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).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
69
Participants will undergo a three component intervention consisting of (1) daily, adaptive text messages related to Positive Psychology or health behaviors, (2) twice weekly text messages related to a specific health behavior goal, and (3) three brief check-ins (at baseline, week 4, and week 8 of the intervention) with a study staff member to discuss progress towards health behavior goals. During the brief check-ins, the study staff member will inquire about: (1) medical conditions, (2) adherence gaps, (3) personal health goals (including weight goals), (4) motivation, self-efficacy, and barriers to reaching health goals, (5) preferred activity types (e.g., walking), and (6) sources of sedentary time (e.g., computer, TV). This information will be added to the algorithm for each individual and we will deliver tailored daily text messages for our participants.
Massachusetts General Hospital
Boston, Massachusetts, United States
Proportion of messages correctly delivered
Proportion of adaptive TMI messages correctly selected/sent will be included as a measure of feasibility.
Time frame: 12 weeks
Rates of feedback to individual text messages
Rates of feedback to individual text messages will be included as a measure of feasibility.
Time frame: 12 weeks
Participant's mean ratings of message utility to measure acceptability of the text-message intervention
0-10 Likert scale score regarding the utility of that day's text message
Time frame: 12 weeks
Change in Positive and Negative Affect Schedule (PANAS) Score
The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Higher scores indicate higher levels of positive affect. The measure will be used at baseline, 12 weeks and 24 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Life Orientation Test-Revised Score
Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Higher scores indicate higher levels of optimism. The measure will be used at baseline, 12 weeks and 24 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Change in General Self-Efficacy Scale score
The General Self-Efficacy Scale is a self-report measure of self-efficacy. The total score ranges from 10-40, with a higher score indicating more self-efficacy.
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Time frame: Baseline, 12 weeks and 24 weeks
Change in HADS-A Score
The anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A) will be used to measure anxiety. This is a well-validated scale with few somatic symptom items that can confound anxiety assessment in medically-ill patients. (Range: 0-21) Higher scores indicate higher levels of anxiety. The measure will be used at baseline, 12 weeks, and 24 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Change in HADS-D Score
The depression subscale of the Hospital Anxiety and Depression Scale (HADS-D) will be used to measure depression. This is a well-validated scale with few somatic symptom items that can confound mood assessment in medically-ill patients.(Range: 0-21). Higher scores indicate worse outcome (i.e. greater levels of depression). The measure will be used at baseline, 12 weeks, and 24 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Health Locus of Control Score
This is an 18-item instrument that measures three dimensions of locus of control. It assesses people's beliefs that their health is or is not determined by their own behavior. The survey has three subscales: internality of health locus of control, powerful other locus of control, and chance locus of control. All items are measured on a 6-point Likert scale, and our main subscale of interest will be internal locus of control, which will be a sum of scores from questions 1,6,8,12,13,17 (range: 6-36). Higher scores indicate higher locus of control.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Multidimensional Scale of Perceived Social Support Score
The MSPSS is a 12-item scale designed to measure perceived social support from three sources: Family, Friends, and a Significant Other. It is rated on a 7-point likert scale, ranging from 1 "very strongly disagree" to 7 "very strongly agree." Each subscale score can range from 4 to 28. Items are summed, and a total score is also calculated and ranges from 12 to 84. Higher subscale and total scores indicate high levels of perceived social support.
Time frame: Baseline, 12 weeks and 24 weeks
Change in MEDFICTS score
MEDFICTS is a screening instrument for dietary fat to assess adherence to the Adult Treatment Panel (ATP) III Therapeutic Lifestyle Changes (TLC) diet. The test measures the intake of meats, eggs, dairy, fried foods, fats in baked goods, convenience foods, table fats, and snacks. Higher scores indicate higher fat consumption.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Behavioral Risk Factor Surveillance System [BRFSS] Fruit and Vegetable Consumption Module
The CDC's BRFSS Fruit and Vegetable Module is a brief questionnaire about frequency of eating different types of fruits and vegetables. It assesses the frequency of consumption of 100% fruit juice, fruit, beans (legumes), dark green vegetables, orange vegetables, and other vegetables over the past month. The outcome measure is the number of fruits or vegetables consumed per day.
Time frame: Baseline, 12 weeks and 24 weeks
Change in Moderate to vigorous physical activity (minutes) measured via accelerometer
Measured by Actigraph accelerometer, in minutes per day.
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical activity (steps) measured via accelerometer
Measured by Actigraph accelerometer, in number of steps per day.
Time frame: Baseline, 12 weeks and 24 weeks
Change in sedentary time measured via accelerometer
Measured by Actigraph accelerometer, in minutes per day.
Time frame: Baseline, 12 weeks and 24 weeks
Change in self-report physical activity time measured by International Physical Activity Questionnaire
Measured by the self-report International Physical Activity Questionnaire (IPAQ). The measure assess the types of intensity of physical activity that people do as part of their daily lives. All activities are converted to multiples of resting energy expenditure (MET) minutes per week. The measure will be used at baseline, 12 weeks, and 24 weeks.
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical function measured by PROMIS 20-item
Measured by the 20-item short form of the Patient-Reported Outcomes Measurement Information System (PROMIS), a well-validated measure of physical function that is highly responsive to changes in a patient's physical function status (Range: 20-100). Higher scores indicate better physical function.
Time frame: Baseline, 12 weeks and 24 weeks
Change in physical function measured by 6-minute test
The 6-minute walk test is a test to measure participant's functional capacity, assessing distance walked in meters in 6 minutes.
Time frame: Baseline, 12 weeks and 24 weeks