What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=101). Intervention: PAM intervention vs. Usual care. Primary outcome: Systolic blood pressure at 3 months (MD 9.16, 95% CI 5.69-12.64).

April 26, 2021Open Access

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

Key Result

The PAM intervention improved biochemically validated medication adherence by 20% and reduced systolic blood pressure by 9.16 mmHg compared to usual care at 3 months.

Study Design

Type

RCT (n=101)

Blinding

Single-blind

Randomization

Random permuted blocks, block size 5, 3:2 allocation ratio

Multicenter

Yes

Structured PICO

Does the PAM behavioral intervention improve medication adherence and reduce blood pressure in non-adherent adults with hypertension?

Population

101 non-adherent adults with hypertension and blood pressure >140/90 mmHg from nine UK primary care practices, followed for 3 months.

Intervention

PAM intervention (a 3-month behavioral intervention consisting of a very brief intervention facilitated by a practice nurse, followed by an 84-day tailored text messaging program or smartphone app) added to usual care.

Comparator

Usual care only.

Outcome

Feasibility estimates including recruitment and attrition rates, systolic and diastolic blood pressure, and biochemically validated medication adherence at 3 months.surrogate

A brief behavioral intervention combined with tailored digital support is feasible and shows potential to significantly improve medication adherence and reduce systolic blood pressure in non-adherent hypertensive patients.

Main Result

Mean Difference: 9.16 (95% CI 5.69–12.64)

Absolute Event Rate: 136.9% vs 145.97%

Limitations

Lack of standardised measurement of blood pressure across practices.
Small number of patients identified as non-adherent by urine analysis at baseline despite GP assessment.
Biochemical analysis might deem patients adherent based on a single dose taken within 40 hours before collection.
Short duration of the trial (3 months).

Abstract

The PAM intervention is a behavioural intervention to support adherence to anti-hypertensive medications and therefore to lower blood pressure. This feasibility trial recruited 101 nonadherent patients (54% male, mean age 65.8 years) with hypertension and high blood pressure from nine general practices in the UK. The trial had 15.5% uptake and 7.9% attrition rate. Patients were randomly allocated to two groups: the intervention group (n = 61) received the PAM intervention as an adjunct to usual care; the control group (n = 40) received usual care only. At 3 months, biochemically validated medication adherence was improved by 20% (95% CI 3-36%) in the intervention than control, and systolic blood pressure was reduced by 9.16 mmHg (95% CI 5.69-12.64) in intervention than control. Improvements in medication adherence and reductions in blood pressure suggested potential intervention effectiveness. For a subsample of patients, improvements in medication adherence and reductions in full lipid profile (cholesterol 1.39 mmol/mol 95% CI 0.64-1.40) and in glycated haemoglobin (3.08 mmol/mol, 95% CI 0.42-5.73) favoured the intervention. A larger trial will obtain rigorous evidence about the potential clinical effectiveness and cost-effectiveness of the intervention.Trial registration Trial date of first registration 28/01/2019. ISRCTN74504989. https://doi.org/10.1186/ISRCTN74504989 .

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