Adherence therapy for people with hypertension

ISRCTN	ISRCTN99494659
DOI	https://doi.org/10.1186/ISRCTN99494659
Secondary identifying numbers	N/A

Submission date: 23/07/2009
Registration date: 27/08/2009
Last edited: 21/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Richard Gray
Scientific

School of Nursing and Midwifery
Faculty of Health
University of East Anglia
Edith Cavell Building
Norwich
NG4 7TJ
United Kingdom

Phone	+44 (0)1603 597 008
Email	Richard.gray@uea.ac.uk

Study information

Study design	Single-blind exploratory randomised parallel group controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Adherence therapy for people with hypertension: a randomised controlled trial
Study acronym	AT BMQ
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	10/08/2009
Completion date	30/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	136
Total final enrolment	136
Key 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)
Key exclusion criteria	1. Diabetes 2. Congestive heart failure 3. Mentally ill 4. Serious disease conditions 5. Pregnant women with hypertension
Date of first enrolment	10/08/2009
Date of final enrolment	30/12/2009

Locations

Countries of recruitment

England
Jordan
United Kingdom

Study participating centre

School of Nursing and Midwifery

Norwich
NG4 7TJ
United Kingdom

Sponsor information

University of East Anglia (UK)
University/education

School of Nursing and Midwifery
Faculty of Health
Edith Cavell Building
Norwich
NR4 7TJ
England
United Kingdom

Phone	+44 (0)1603 597 047
Email	f.al-halaiqa@uea.ac.uk
Website	http://www.uea.ac.uk/
"ROR"	https://ror.org/026k5mg93

Funders

Funder type

Other

Investigator initiated and funded (Jordan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2012	21/05/2020	Yes	No

Editorial Notes

21/05/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.