To improve the adherence of hypertension treatment among hypertension patients in Gaza.
Design
Two arm parallel group randomized controlled trial with non blinded behavioral change counseling and outcome assessment
Settings and conduct
Hypertension patients attending ten governmental primary health centers in Gaza strip will be assessed for antihypertensive medication adherence (AMA). Five centers will be the control. Other five centers will have behavioral counseling about AMA. Three motivational interviewing (MI) sessions will be done to improve adherence. AMA will be reassessed after intervention in both control and intervention centers. Not blinded trial.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Palestinian resident who received his usual care in government primary health center, aged 18 years or older with confirmed diagnosis of hypertension, and taking at least one antihypertensive medication. Exclusion Criteria: Have a diagnosis of cognitive impairment or serious medical condition as determined by their primary care physician or unable to provide informed consent or refuse to participate.
Intervention groups
Intervention group: patients randomized to this group will receive their usual hypertension medications plus behavioral counseling about medication adherence. A standardized structured adherence script will be used to improve self-efficacy and intrinsic motivations. This is proposed to be done through monthly motivational interviewing session for three months.
Control group: patients randomized to this group will receive their usual hypertension medications only.
Main outcome variables
Primary outcome: Antihypertensive medication adherence score change. Secondary outcomes: within-patient changes in blood pressure and within-patient score changes in self-efficacy and intrinsic motivation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180705040352N1
Registration date:2018-09-13, 1397/06/22
Registration timing:prospective
Last update:2018-09-13, 1397/06/22
Update count:0
Registration date
2018-09-13, 1397/06/22
Registrant information
Name
Khalid Khadoura
Name of organization / entity
Country
Palestine, State of
Phone
+970 8 282 7711
Email address
kh-khadoura@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-30, 1397/07/08
Expected recruitment end date
2019-01-15, 1397/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of motivational interviewing among non-adherence hypertensive patients in Palestine: a cluster randomized control trial
Public title
Effect of motivational sessions in improving hypertension medication adherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Palestinian resident who received his usual care in government primary centers
Age 18 years or older
Confirmed diagnosis of hypertension
Taking at least one antihypertensive medication
Exclusion criteria:
Have a diagnosis of cognitive impairment or serious medical condition as determined by their primary care physician
Unable to provide informed consent or refuse to participate
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
364
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is two stages cluster random sampling, stratified simple random sampling and systematic random sampling.
Unit of randomization in stratified simple random is cluster.
Unit of randomization in systematic random sampling is individual.
Randomization strata is each governorate as one strata
Tools will be used in Randomization is table of random numbers.
Random sequences is built by selecting two centers from each governorate (strata), so selecting two tickets from pot containing all centers in each strata will be done, then sampling fraction will be calculated to recruit a proportion of the patients from each center. A list of all patients in the center will be prepared, then random number table will be used to select the first patient. Allocation concealment is not carried out.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Before intervention and after one month from completing the intervention
Method of measurement
Morisky medication adherence scale (MMAS-8).
Secondary outcomes
1
Description
Within-patient difference in blood pressure
Timepoint
Before intervention and one month after intervention
Method of measurement
Sphygmomanometer
2
Description
Within-patient difference in self-efficacy
Timepoint
Before intervention and one month after intervention
Method of measurement
Self-efficacy scale
3
Description
Within-patient difference in intrinsic motivation scores
Timepoint
Before intervention and one month after intervention
Method of measurement
Intrinsic motivation scale by Treatment Self-Regulation Questionnaire (TSRQ)
Intervention groups
1
Description
Intervention group: hypertensive patients receive both usual care of hypertension plus motivational interviewing for three months in primary health centers which was randomly allocated to be intervention centers. Participants in each intervention group will attend three motivational interviewing (MI) sessions which will be conducted monthly for three months. The initial session will be individual session may need about 20 minutes by trained research assistants (RA) with the aid of a standardized structured adherence counseling script. Two follow-up sessions will be done by group discussion sessions to discuss treatment adherence by lifestyle modification (e.g. salt intake, physical exercise, smoking cessation) and to let patients share their experiences. The time expected nearly 20-30 minutes for each. RA will work as a facilitator to manage the first session and highlights the importance of lifestyle modification. In the second session the RA will provide some strategies to achieve lifestyle modification. The individual MI sessions compromises of the following sequential steps: 1. Assess the patient's motivation and confidence: The trained RA will assesses motivation and confidence with the following questions: a. On a scale of 1 to 10 (10 is the highest), how motivated/interested are you in taking your blood pressure medication as prescribed? b. On a scale of 1 to 10 (10 is the highest), assuming you want to, how confident are you that you can take your blood pressure medication as prescribed? 2. Elicit barriers, concerns and positive self-motivational statements: depending on the patient's response to the motivation/confidence questions above, the RA then will ask the patient the following questions: a. Why did you not choose a lower number, like a 1 or 2? (this elicits positive motivational statements). b. Why did you not choose a higher number (this elicits barriers) or what will it take to get you to a 9 or 10? 3. Summary of pros and cons: The RA next will summarize the patient's pros and cons, and asks if there was anything else that she/he wanted to add. Provide menu of options: If barriers were presented, the RA then will prompt the patient to offer solutions. After the patient will exhaust her/his own solutions (or in the event that none were offered), the RA will seek permission to list other solutions “that have worked for other people”. 4. Assess patient's values and goals: Patients will asked to complete a values-clarification list to help link their medication adherence and health to other core values and life goals. This helps to create ambivalence between current behavior and goals and values. Patients will be asked to sort a list of approximately 29 values in terms of personal importance and to select around 5 that are most important. Then they will be asked to briefly discuss why the values/goals selected are important to them and then they will explore what connection if any, they will see between their current health behavior and their ability to achieve these goals or live out these values. Alternatively, the RA may ask how changing their health behavior may be related to these goals or values. 5.Clarify contract and global summary: The interview, when appropriate, ends with a behavioral contract for the patient to try at least one of the solutions offered. Again the RA summarizes what was agreed upon and incorporates patients' suggestions.
Category
Behavior
2
Description
Control group: hypertensive patients receive usual care of hypertension in governmental primary health centers which will be randomly allocated to be control centers.