Condition category
Circulatory System
Date applied
23/07/2009
Date assigned
27/08/2009
Last edited
15/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Richard Gray

ORCID ID

Contact details

School of Nursing and Midwifery
Faculty of Health
University of East Anglia
Edith Cavell Building
Norwich
NG4 7TJ
United Kingdom
+44 (0)1603 597 008
Richard.gray@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Adherence therapy for people with hypertension: a randomised controlled trial

Acronym

AT BMQ

Study hypothesis

Current information as of 15/03/10:
1. Advanced Therapy (AT) reduces systolic blood pressure (SBP) in Jordanian people with hypertension at seven weeks, compared to treatments as usual.
2. AT reduce diastolic blood pressure (DBP) in Jordanian people with hypertension compared to treatments as usual.
3. AT improves adherence in Jordanian people with hypertension compared to treatments as usual.
4. AT improves attitudes and beliefs toward medication in Jordanian people with hypertension compared to usual care.

Initial information at time of registration:
1. Adherence therapy (AT) reduces systolic blood pressure in Jordanian people with hypertension at eight weeks, compared to treatment as usual
2. AT improves adherence in Jordanian people with hypertension compared to treatment as usual
3. AT improves attitudes and beliefs toward medication in Jordanian people with hypertension compared to usual care

Please note that as of 15/03/10 this record has been updated to include changes in the hypothesis, inclusion criteria and secondary outcomes. All updates can be found in the relevant field with the above update date.

Ethics approval

1. Jordanian Ministry of Health Ethics Committee approved on the 18th June 2009
2. Unversity of East Anglia Ethical Committee approved on the 23rd July 2009

Study design

Single-blind exploratory randomised parallel group controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hypertension

Intervention

Intervention:
Based on cognitive behavioural approaches derived from compliance therapy, adherence therapy consists of:
1. Engagement
2. Assessment
3. Ratings of readiness to take medication
4. Therapy
5. Evaluation
The therapist works in a flexible, patient-centered and structured way to promote a shared decision with the patient about treatment. Patients receive eight weekly sessions of adherence therapy.

Control:
Treatment as usual for 8 weeks.

Patients will be followed up for one month after intervention/control.

Contact Details for Joint Principal Investigators:
Mrs F Alhaliqa
School of Nursing and Midwifery
Faculty of Health
University of East Anglia
Edith Cavell Building
Norwich NG4 7TJ
United Kingdom
Email: F.AL-Halaiqa@uea.ac.uk

Dr K Deane
Faculty of Health
University of East Anglia
Edith Cavell Building
Norwich NG4 7TJ
United Kingdom
Email: K.Deane@uea.ac.uk

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Systolic blood pressure reduction, measured in mmHg, measured after one month from the end of sessions.

Secondary outcome measures

1. Correct dosing of drugs, defined as percentage of prescribed doses taken during the research interval. Assessed by pill-counting after one month from the end of sessions for each participant according to the given doses.
2. Attitude and beliefs with medication, measured by using the Beliefs About Medication Questionnaire (BMQ)
3. Satisfaction with adherence therapy, determined by interviews conducted one month from the end of sessions

Added 15/03/10:
4. Patient diastolic blood pressure measured in mmHg

Overall trial start date

10/08/2009

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with hypertension
2. On monthly follow up schedule
3. Blood pressure greater than 140/90 mmHg
4. Written consent
5. Aged above or equal to 18 years, either sex

Added 15/03/10:
6. Non-adhered patients based on Morisky Medication Adherence Scale (MMAS)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

136

Participant exclusion criteria

1. Diabetes
2. Congestive heart failure
3. Mentally ill
4. Serious disease conditions
5. Pregnant women with hypertension

Recruitment start date

10/08/2009

Recruitment end date

30/12/2009

Locations

Countries of recruitment

Jordan

Trial participating centre

School of Nursing and Midwifery
Norwich
NG4 7TJ
United Kingdom

Sponsor information

Organisation

University of East Anglia (UK)

Sponsor details

School of Nursing and Midwifery
Faculty of Health
Edith Cavell Building
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 597 047
f.al-halaiqa@uea.ac.uk

Sponsor type

University/education

Website

http://www.uea.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Jordan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes