The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial

Kassavou, Aikaterini; Mirzaei, Venus; Shpendi, Sonia; Brimicombe, James; Chauhan, Jagmohan; Bhattacharya, Debi; Naughton, Felix; Hardeman, Wendy; Eborall, Helen; Emmenis, Miranda Van; Simoni, Anna De; Takhar, Amrit; Gupta, Pankaj; Patel, Prashanth; Mascolo, Cecilia; Prevost, A. Toby; Morris, Stephen; Griffin, Simon J.; McManus, Richard J; Mant, Jonathan; Sutton, Stephen

doi:10.1038/s41598-021-88170-2

Cited by 5 publications

(2 citation statements)

References 28 publications

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“…This may have led to greater reduction in BP than may have been experienced with standard usual care alone.The high dropout rate (58.6%) among enrolled and randomized participants warrants further mention. While this dropout rate is higher than other studies that involved similar digital interventions for monitoring and controlling BP and/or study populations[26][27][28], high dropout rates in studies that deployed digital health interventions are quite common in the mHealth domain and range upwards of 80% attrition, with about 49% attrition in observational studies and 40% attrition in RCTs. In his seminal piece, Eysenbach described The Law of Attrition for eHealth interventions, which describes the phenomenon of participants dropping out of a research trial prior to completion, or stopping their usage of the trial intervention before the study is over[29]…”

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confidence: 69%

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Buis,

Kim,

Sen

et al. 2024

Preprint

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BACKGROUND Hypertension (HTN) is one of the most important cardiovascular disease risk factors and affects over 100 million American adults. HTN-related health inequities are abundant in Black communities as Blacks are more likely to utilize the emergency department (ED) for chronic disease-related ambulatory care, which is strongly linked to lower BP control, diminished awareness of HTN, and adverse cardiovascular events. To reduce HTN-related health disparities, we developed MI-BP, a culturally tailed multi-behavior mHealth intervention that targeted behaviors of blood pressure self-monitoring, physical activity, sodium intake, and medication adherence in Blacks with uncontrolled HTN who were recruited from ED and community-based settings. OBJECTIVE We sought to determine the effect of MI-BP on BP, as well as secondary outcomes of physical activity, sodium intake, and medication adherence, compared to enhanced usual care control at one-year follow-up. METHODS We conducted a one-year, two-group RCT of the MI-BP intervention compared to an enhanced usual care where participants received a blood pressure cuff. Participants were recruited from EDs and other community-based settings in Detroit, MI, where they were screened for initial eligibility and enrolled. Baseline data collection and randomization occurred about 2- and 4-weeks after enrollment to ensure participants had uncontrolled hypertension and were willing to participate. Data collection visits occurred at 13-, 26-, 39-, and 52-weeks. Outcomes of interest included BP (primary outcome), as well as physical activity, sodium intake, and medication adherence (secondary outcomes). RESULTS We consented and enrolled 869 participants in this study, yet ultimately randomized 162 participants. At one-year, compared to baseline, both groups demonstrated significant decreases in SBP (MI-BP = 22.5 mmHg decrease in average SBP, p < .0001; control group = 24.1 mmHg decrease, p < .0001), adjusted for age and sex, with no significant differences between groups (time-by-arm interaction p = .99). Similar patterns, where improvements were noted for both groups, yet no differences were found between groups, were demonstrated for diastolic BP, physical activity, sodium intake, and medication adherence. Large dropout rates were observed for both groups (about 60%). CONCLUSIONS Overall, participants randomized to both the enhanced usual care control and MI-BP conditions experienced significant improvements in blood pressure and other outcomes, however, differences between groups were not detected, speaking to the general benefit of proactive outreach and engagement focused on cardiometabolic risk reduction in urban dwelling, low-SES Black populations. High rates of dropout were found and are likely to be expected when working in similar populations. Future work is needed to better understand engagement with mHealth interventions, particularly in this population. CLINICALTRIAL ClinicalTrials.gov NCT02360293; http://clinicaltrials.gov/ct2/show/NCT02360293. International registered report identifier (irrid): RR1-10.2196/12601. INTERNATIONAL REGISTERED REPORT RR2-10.2196/12601

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mentioning

confidence: 69%

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Buis,

Kim,

Sen

et al. 2024

Preprint

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“…In the future, we plan to take additional measures of adherence (eg, from medical records) so that the relationships between these constructs, self-reported adherence, and adherence measured through more direct means can be explored. Future work could also explore the use of objective measures of medication adherence, such as urine samples [ 33 ]. Overall, this study provides a more detailed picture of the potential mechanism of action for this intervention, which can be used to support development of further interventions for this target behavior.…”

Section: Discussionmentioning

confidence: 99%

Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study

Bartlett¹,

Farmer²,

Newhouse³

et al. 2022

JMIR Form Res

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Background Poor adherence to oral medications is common in people with type 2 diabetes and can lead to an increased chance of health complications. Text messages may provide an effective delivery method for an intervention; however, thus far, the majority of these interventions do not specify either a theoretical basis or propose specific mechanisms of action. This makes it hard to determine how and whether an intervention is having an effect. The text messages included in the current intervention have been developed to deliver specific behavior change techniques. These techniques are the “active ingredients” of the intervention and were selected to target psychological constructs identified as predictors of medication adherence. Objective There are 2 aims of this study: (1) to assess whether a text message intervention with specified behavior change techniques can change the constructs that predict medication adherence behaviors in people with type 2 diabetes and (2) to assess whether changes to psychological constructs are associated with changes in self-reported medication adherence. Methods We conducted a randomized controlled, 6-month feasibility trial. Adults prescribed oral medication for type 2 diabetes (N=209) were recruited from general practice and randomized to either receive a text message–based intervention or care as usual. Data were analyzed with repeated measures analysis of covariance and Spearman rho correlation coefficients. Results For 8 of the 14 constructs that were measured, a significant time-by-condition interaction was found: necessity beliefs, intention, maintenance self-efficacy, recovery self-efficacy, action control, prompts and cues, social support, and satisfaction with experienced consequences all increased in the intervention group compared to the control group. Changes in action self-efficacy, intention, automaticity, maintenance self-efficacy, and satisfaction with experienced consequences were positively associated with changes in self-reported medication adherence. Conclusions A relatively low-cost, scalable, text message–only intervention targeting medication adherence using behavior change techniques can influence psychological constructs that predict adherence. Not only do these constructs predict self-reported medication adherence, but changes in these constructs are correlated with changes in self-reported medication adherence. These findings support the promise of text message–based interventions for medication adherence in this population and suggest likely mechanisms of action. Trial Registration ISRCTN Registry ISRCTN13404264; https://www.isrctn.com/ISRCTN13404264

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Effectiveness of digital health interventions for telemedicine/telehealth for managing blood pressure in adults: a systematic review and meta-analysis

Sakima,

Akagi,

Akasaki

et al. 2024

Hypertens Res

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The feasibility of the PAM intervention to support treatment-adherence in people with hypertension in primary care: a randomised clinical controlled trial

Cited by 5 publications

References 28 publications

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

The Effect of an mHealth Self-Monitoring Intervention (MI-BP) on Blood Pressure Among Black Individuals With Uncontrolled Hypertension: Randomized Controlled Trial (Preprint)

Effects of Using a Text Message Intervention on Psychological Constructs and the Association Between Changes to Psychological Constructs and Medication Adherence in People With Type 2 Diabetes: Results From a Randomized Controlled Feasibility Study

Effectiveness of digital health interventions for telemedicine/telehealth for managing blood pressure in adults: a systematic review and meta-analysis

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