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IRCT20180705040352N1 IRCT 2018-09-13 Tehran University of Medical Sciences Effect of motivational sessions in improving hypertension medication adherence Effectiveness of motivational interviewing among non-adherence hypertensive patients in Palestine: a cluster randomized control trial 2018-09-30 anticipated 364 Complete https://irct.ir/trial/32440 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Hypertension. Intervention 1: 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. Intervention 2: Control group: hypertensive patients receive usual care of hypertension in governmental primary health centers which will be randomly allocated to be control centers. Yes - There is a plan to make this available What will be shared: All collected deidentified individual participant data in this study would be available to other researchers after publication of the results. When: When summary data are published To whom: For people working in academic institutions Conditions: For academic purposes, criteria will be decided by researchers later. Where to obtain: Tehran University of Medical Sciences and authors. How to obtain: Email correspondent author researcher and explain the need. Comments: Tehran University of Medical Sciences agreement must be obtained as well.
public Khalid Jamal Khadoura
No. 36, Nakheel st., Deir El Balah, Gaza strip, Palestine
Gaza Palestine, State of 79730 +970 843433 k.khadourah@gmail.com Tehran University of Medical Sciences scientific Khalid Jamal Khadoura
No. 36, Nakheel st., Deir El Balah, Gaza strip, Palestine
Gaza Palestine, State of 79730 +970 843433 k.khadourah@gmail.com Tehran University of Medical Sciences Palestine, State of Palestine, State of 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 18 years no limit Both 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 I10 Essential (primary) hypertension Behavior N/A 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. Control group: hypertensive patients receive usual care of hypertension in governmental primary health centers which will be randomly allocated to be control centers. Antihypertensive medication adherence. Timepoint: Before intervention and after one month from completing the intervention. Method of measurement: Morisky medication adherence scale (MMAS-8). Within-patient difference in blood pressure. Timepoint: Before intervention and one month after intervention. Method of measurement: Sphygmomanometer. Within-patient difference in self-efficacy. Timepoint: Before intervention and one month after intervention. Method of measurement: Self-efficacy scale. 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). Tehran University of Medical Sciences Approved 2018-03-18 Ethics committee of Tehran University of Medical Sciences No. 3, 1st St., Hijab St., Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)