The use of health belief derived interventions to improve the ability of patients to take medicines for pulmonary arterial hypertension

Evaluating the use of a theory-based intervention to improve medication-taking behaviours: s longitudinal study in patients with pulmonary arterial hypertension

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN41973090

Enrollment

Registered

2018-10-16

Start date

2017-10-01

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH) Circulatory System Pulmonary arterial hypertension (PAH)

Interventions

As this is a longitudinal study, all participants will act as their own control. Medication adherence (defined using the medicines adherence rating scale (MARS), and PAH medication counts) will be ass

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH) 2. Attending the regional outpatient pulmonary hypertension clinic in the Belfast Trust hospitals (UK) 3. Aged 18 years or over 4. Have a life-expectancy of at least 1 year (assessed by consultant within clinic) 5. Receiving at least one targeted medicine for PAH 6. No significant dementia or learning disability (assessed by consultant within study) 7. Ability to provide full and informed consent 8. Fluent in verbal and written English

Exclusion criteria

Exclusion criteria: 1. No capacity to consent 2. Patients in whom there is reason to believe will not complete study 3. Current illicit drug use or dependency

Design outcomes

Primary

Measure	Time frame
1. Changes in medication adherence, assessed using the Medication Adherence Rating Scale (MARS). MARS is assessed each month by participant. The analysis will compare the average score of MARS from months 0-3 with the average MARS score from months 9-12 2. Change in patient medication beliefs, assessed using the following between months 3 and 12: 2.1. Changes in thematic outcomes obtained from the patient population of a semi-structured interviews between the two time points using interpretive phenomenological analysis (IPA) 2.2. Changes in Beliefs about Medication Questionnaire (BMQ) between the two time points. This will be analysed as intra-patient differences in addition to population differences and as differences in beliefs between high adherent and low adherent groups	—

Measure

Time frame

1. Changes in medication adherence, assessed using the Medication Adherence Rating Scale (MARS). MARS is assessed each month by participant. The analysis will compare the average score of MARS from months 0-3 with the average MARS score from months 9-12 2. Change in patient medication beliefs, assessed using the following between months 3 and 12: 2.1. Changes in thematic outcomes obtained from the patient population of a semi-structured interviews between the two time points using interpretive phenomenological analysis (IPA) 2.2. Changes in Beliefs about Medication Questionnaire (BMQ) between the two time points. This will be analysed as intra-patient differences in addition to population differences and as differences in beliefs between high adherent and low adherent groups

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Secondary

Measure	Time frame
1. Relationship between patient psychological wellbeing and medication adherence, assessed over the 12 month study period. Psychological wellbeing is assessed using the Depression, Anxiety, Stress Scale (DASS) and medication adherence is assessed using the Medication Adherence Rating Scale (MARS). ). Each participant will complete both questionnaire each month for a total of 12 months. The analysis will examine the relationship between the two scales 2. Change in participant medication burden, assessed using a bespoke study scale over the 12 month period. Medication burden is collected at the baseline and at months 3, 6, 9 and 12. The study will examine whether there is a relationship between variations in medication adherence and other study measures (medication adherence, disease parameters, DASS-21 score) 3. Change in medication adherence, assessed using monthly MARS over the 12 month period 4. The relationship between quality of life measurements at the baseline and at months 3, 6, 9 and 12 with other study parameters (medication burden, disease burden, medication adherence, DASS-21), assessed using the following: 4.1. Short Form Health Survey (SF-36) questionnaire to capture global quality of life 4.2. EMPHASIS-10 questionnaire to capture disease specific indices	—

Measure

Time frame

1. Relationship between patient psychological wellbeing and medication adherence, assessed over the 12 month study period. Psychological wellbeing is assessed using the Depression, Anxiety, Stress Scale (DASS) and medication adherence is assessed using the Medication Adherence Rating Scale (MARS). ). Each participant will complete both questionnaire each month for a total of 12 months. The analysis will examine the relationship between the two scales 2. Change in participant medication burden, assessed using a bespoke study scale over the 12 month period. Medication burden is collected at the baseline and at months 3, 6, 9 and 12. The study will examine whether there is a relationship between variations in medication adherence and other study measures (medication adherence, disease parameters, DASS-21 score) 3. Change in medication adherence, assessed using monthly MARS over the 12 month period 4. The relationship between quality of life measurements at the baseline and at months 3, 6, 9 and 12 with other study parameters (medication burden, disease burden, medication adherence, DASS-21), assessed using the following: 4.1. Short Form Health Survey (SF-36) questionnaire to capture global quality of life 4.2. EMPHASIS-10 questionnaire to capture disease specific indices

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026