Treatment Adherence and ComplianceNCT05106790
A Factorial Approach to Improve Treatment Adherence and Systolic Blood Pressure
A study testing Educational support with peer counseling, mHealth intervention and mHealth intervention and Educational support with peer counseling in people with Treatment Adherence and Compliance, run by Universiti Putra Malaysia at 6 sites in Pakistan.
Trial summary
In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Treatment Adherence and Compliance
- What is being tested?
- Educational support with peer counseling, mHealth intervention and mHealth intervention and Educational support with peer counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 6 sitesPakistan
- Study dates
- 1 Jul 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with age 21 to 70 years
- Participants who have been registered as hypertensive with comorbidity of coronary artery disease in the Outpatient Departments (OPDs) of one of the three public teaching hospitals in Lahore, for at least last one month
- Participants on antihypertensive drugs
- The participants with stable coronary artery disease who are treated in an outpatient setting
- Participants who are willing to sign a written informed consent form, must have a smartphone with the WhatsApp application installed and be able to read Urdu/English.
- Participants with smartphones and have internet access
Who cannot join
- Participants who suffer from some type of malignancy and require adjustment of drugs
- Participants with any biological condition that makes it difficult for them to read write, communicate or hear phone calls
- Participants in hypertensive emergency blood pressure >220/120 mmHg
- Participants with pregnancy(self-reporting)
- Participants in their period of lactation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Pakistan6 sites
Victoria Hospital
Bahawalpur, Punjab Province, 63100
Arshed MUHAMMAD, +923337474464, drarshedchaudhary@gmail.com
Jinnah Hospital
Lahore, 54000
Arshed MUHAMMAD, MBBS, +923337474464, drarshedchaudhary@gmail.com
Punjab Institute of Cardiology
Lahore, 54000
Arshed MUHAMMAD, +923337474464, drarshedchaudhary@gmail.com
Rehmatul-lil-Almeen Institute of Cardiology
Lahore, 54000
Arshed MUHAMMAD, MBBS, 00923337474464, drarshedchaudhary@gmail.com
Kiran Mehwish, MBBS, 00923150228348, kiranmehwish47@gmail.com
Sheikh Zayed, Hospital
Lahore, 54000
Arshed MUHAMMAD, MBBS, +923337474464, drarshedchaudhary@gmail.com
Maaz Arif Muhammad, MBBS, 00923481816881, maazarifbutt@gmail.com
Sheikh Zayed Hospital Rahim Yar Khan
Rahim Yar Khan, Punjab Province, 64200
About this study
Official title: Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan
In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. On the other hand, conservative approaches to counseling are also found effective. This study will look at how a mHealth-based strategy and an educational-led peer counseling intervention can help hypertensive patients with coronary artery disease lower their systolic blood pressure.
Read the detailed description
In Pakistan, hypertension is a serious public health concern. Hypertension affects 18.9% of teenagers over the age of 15 and 33% of adults over the age of 45; however, only around 3% of hypertensive individuals have their blood pressure regulated to 140/90 mm Hg or lower. The majority of hypertensive patients are found to have blood pressure that is out of control. The majority of those undergoing therapies were judged to be non-compliant. According to the study, adherence to cardiac medications ranged from 27 to 77 percent, while adherence to stroke medications was around 68 percent. According to a recent study, 37.7% of patients did not take their antihypertensive medication as advised.
Interventions to help hypertensive patients in controlling blood pressure show potential to alter their behavior and lead to better outcomes, but delivering them at a cheap cost is difficult. Although evidence is scarce, several trials examining clinical interventions utilizing conventional health education support while others employing a mobile health strategy, both showed significant results. For a low-resource country, we built cost-effective models that are integrated with clinical care for patients with hypertension. The goal of this trial is to assess the effectiveness of mHealth intervention with clinical educational support and educational support with peer counseling to improve blood pressure control in hypertensive patients when compared to standard care.
- Conditions
- Treatment Adherence and Compliance
- Being tested
- Educational support with peer counseling, mHealth intervention, mHealth intervention and Educational support with peer counseling
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational support with peer counselingBehavioural
This group will receive peer counseling therapy sessions will be led by doctors who specialize in hypertension. Patients and their families will be the focus of the sessions. Face-to-face sessions will take roughly 25-30 minutes. Patients will receive spoken and written instructions based on their abilities during these sessions. The counseling sessions are geared toward overcoming both general and personal obstacles. The educational component will be delivered through smart booklets. Information on hypertension, blood pressure self-monitoring, and frequent systolic blood pressure (SBP) tests, as well as body weight and serum cholesterol values, are included in the instructional support. Food control, exercise therapy, and hypertension problems and their management will also be explored as non-pharmacological therapeutic approaches.
mHealth interventionBehavioural
This group will receive mHealth intervention will include daily written and voice messages, and once weekly an educational-led video. This intervention module will be delivered through "WhatsApp".
mHealth intervention and Educational support with peer counselingBehavioural
This group will receive both Educational support (Smart booklets) with peer counseling sessions on a monthly basis and mHealth intervention will include daily written and voice reminders, and once weekly an educational led video.
| Study group | Role | What they receive |
|---|---|---|
| Standard care arm | No intervention | The first group will be on standard care as usually being practiced in hospitals. |
| Ed-counseling arm | Active comparator | The second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care. Receives: Behavioral: Educational support with peer counseling |
| mHealth | Active comparator | The third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care. Receives: Behavioral: mHealth intervention |
| Combined arm | Active comparator | The fourth group will receive educational support (booklets)and counseling sessions every month, daily written and voice reminders, and once weekly an education-led video in addition to standard care. Receives: Behavioral: mHealth intervention and Educational support with peer counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure (SBP)
The primary outcome is a change in systolic blood pressure (SBP) of participants at 0, 6, and 12 months. The blood pressure will be recorded by sphygmomanometer used was calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian). Two separate readings will be taken within 5 min, and the average measurement will be the final. If the difference between the two measurements will be more than 5mmHg, then a third recording will be done and the average is considered.
Measured: 12- month from baseline
Proportion of participants achieving blood pressure < 140/90 mmHg
The proportion of participants achieving the control blood pressure < 140/90 mmHg
Measured: 12- month from baseline
Proportion of participants attending scheduled clinic appointments
The proportion of participants attending scheduled clinic appointments
Measured: 12- month from baseline
Secondary outcomes (1)
Measuring quality of life
To measure the health-related quality of life at baseline, three-month, and 12-month post-intervention, EuroQol 5-Dimension- 3-level will be used. The European quality of life scale (EQ-5D-3L) has five dimensions and three levels. Each of the five dimensions comprising the EQ-5D descriptive system is divided into three levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating some problems LEVEL 3: indicating extreme problems, 1 (perfect health), with higher scores indicating higher health utility.
2- On a 20 cm vertical visual analog scale, the EQ-VAS captures the patient's self-rated health, with two unique endpoints such as "Best imaginable health condition" for a score of 100 and "Worst imaginable health state" for a score of 0.
Measured: 12- month from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Treatment Adherence and ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- It's a 12-month factorial design, intention-to-treat, four-arm, double-blinded, multicentre, pragmatic randomized controlled trial with an intervention to assess the efficacy of mHealth and education support with peer counseling to improve treatment adherence and lower systolic blood pressure in hypertensive patients in three teaching hospitals in Lahore, Pakistan.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
- Investigators
- Arshed MUHAMMAD, Principal investigator, UPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106790
- Sponsor's protocol ID
- APUTRA
- Status last verified
- May 2022
- First submitted
- 23 Oct 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017 Jan 7;389(10064):37-55. doi: 10.1016/S0140-6736(16)31919-5. Epub 2016 Nov 16.
PubMed 27863813Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.
PubMed 12493255NIPS/Pakistan and ICF NI of PS-. Pakistan Demographic and Health Survey 2017-18. 2019 [cited 4 Jan 2021]. Available: https://dhsprogram.com/publications/publication-fr354-dhs-final-reports.cfm
Mahmood S, Jalal Z, Hadi MA, Orooj H, Shah KU. Non-Adherence to Prescribed Antihypertensives in Primary, Secondary and Tertiary Healthcare Settings in Islamabad, Pakistan: A Cross-Sectional Study. Patient Prefer Adherence. 2020 Jan 14;14:73-85. doi: 10.2147/PPA.S235517. eCollection 2020.
PubMed 32021119Zhai P, Hayat K, Ji W, Li Q, Shi L, Atif N, Xu S, Li P, Du Q, Fang Y. Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial. J Med Internet Res. 2020 May 20;22(5):e16019. doi: 10.2196/16019.
PubMed 32432556Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Apr;97(4):380-387. doi: 10.1111/aogs.13309. Epub 2018 Feb 27.
PubMed 29377058Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15(3):203-19. doi: 10.1891/106137407783095757.
PubMed 18232619Strobl J, Cave E, Walley T. Data protection legislation: interpretation and barriers to research. BMJ. 2000 Oct 7;321(7265):890-2. doi: 10.1136/bmj.321.7265.890. No abstract available.
PubMed 11021874Del Re AC, Maisel NC, Blodgett JC, Finney JW. Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders. BMJ Open. 2013 Nov 12;3(11):e003464. doi: 10.1136/bmjopen-2013-003464.
PubMed 24227870Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. doi: 10.1186/1471-2288-3-26.
PubMed 14633287Whelan DB, Dainty K, Chahal J. Efficient designs: factorial randomized trials. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:34-8. doi: 10.2106/JBJS.L.00243.
PubMed 22810445
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of mHealth and Education-led Peer Counseling of Patients With Hypertension and Coronary Artery Disease: a Double-blinded Pragmatic Randomized Control Trial With Factorial Design, Pakistan
- ClinicalTrials.gov ID
- NCT05106790
- Acronym / sponsor ID
- APUTRA
- Conditions
- Treatment Adherence and Compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Pakistan, poor medication adherence is a key operational factor in the prevalence of uncontrolled hypertension. Mobile phone treatments based on technology are at the forefront and are a reasonably low-cost strategy for combating the latest health concerns associated with poor adherence. On the other hand, conservative approaches to counseling are also found effective. This study will look at how a mHealth-based strategy and an educational-led peer counseling intervention can help hypertensive patients with coronary artery disease lower their systolic blood pressure.
Detailed description
In Pakistan, hypertension is a serious public health concern. Hypertension affects 18.9% of teenagers over the age of 15 and 33% of adults over the age of 45; however, only around 3% of hypertensive individuals have their blood pressure regulated to 140/90 mm Hg or lower. The majority of hypertensive patients are found to have blood pressure that is out of control. The majority of those undergoing therapies were judged to be non-compliant. According to the study, adherence to cardiac medications ranged from 27 to 77 percent, while adherence to stroke medications was around 68 percent. According to a recent study, 37.7% of patients did not take their antihypertensive medication as advised.
Interventions to help hypertensive patients in controlling blood pressure show potential to alter their behavior and lead to better outcomes, but delivering them at a cheap cost is difficult. Although evidence is scarce, several trials examining clinical interventions utilizing conventional health education support while others employing a mobile health strategy, both showed significant results. For a low-resource country, we built cost-effective models that are integrated with clinical care for patients with hypertension. The goal of this trial is to assess the effectiveness of mHealth intervention with clinical educational support and educational support with peer counseling to improve blood pressure control in hypertensive patients when compared to standard care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- It's a 12-month factorial design, intention-to-treat, four-arm, double-blinded, multicentre, pragmatic randomized controlled trial with an intervention to assess the efficacy of mHealth and education support with peer counseling to improve treatment adherence and lower systolic blood pressure in hypertensive patients in three teaching hospitals in Lahore, Pakistan.
| Arm | Type | Receives |
|---|---|---|
| Standard care arm | No intervention | –The first group will be on standard care as usually being practiced in hospitals. |
| Ed-counseling arm | Active comparator | Behavioral: Educational support with peer counselingThe second group will receive monthly educational support ( booklets) with peer counseling sessions in addition to standard care. |
| mHealth | Active comparator | Behavioral: mHealth interventionThe third group will receive daily written and voice reminders, and once weekly an education-led video in addition to standard care. |
| Combined arm | Active comparator | Behavioral: mHealth intervention and Educational support with peer counselingThe fourth group will receive educational support (booklets)and counseling sessions every month, daily written and voice reminders, and once weekly an education-led video in addition to standard care. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with age 21 to 70 years
- Participants who have been registered as hypertensive with comorbidity of coronary artery disease in the Outpatient Departments (OPDs) of one of the three public teaching hospitals in Lahore, for at least last one month
- Participants on antihypertensive drugs
- The participants with stable coronary artery disease who are treated in an outpatient setting
- Participants who are willing to sign a written informed consent form, must have a smartphone with the WhatsApp application installed and be able to read Urdu/English.
Key exclusion criteria (5 listed)
- Participants who suffer from some type of malignancy and require adjustment of drugs
- Participants with any biological condition that makes it difficult for them to read write, communicate or hear phone calls
- Participants in hypertensive emergency blood pressure >220/120 mmHg
- Participants with pregnancy(self-reporting)
- Participants in their period of lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational support with peer counselingThis group will receive peer counseling therapy sessions will be led by doctors who specialize in hypertension. Patients and their families will be the focus of the sessions. Face-to-face sessions will take roughly 25-30 minutes. Patients will receive spoken and written instructions based on their abilities during these sessions. The counseling sessions are geared toward overcoming both general and personal obstacles. The educational component will be delivered through smart booklets. Information on hypertension, blood pressure self-monitoring, and frequent systolic blood pressure (SBP) tests, as well as body weight and serum cholesterol values, are included in the instructional support. Food control, exercise therapy, and hypertension problems and their management will also be explored as non-pharmacological therapeutic approaches. | Behavioural | Ed-counseling arm |
| mHealth interventionThis group will receive mHealth intervention will include daily written and voice messages, and once weekly an educational-led video. This intervention module will be delivered through "WhatsApp". | Behavioural | mHealth |
| mHealth intervention and Educational support with peer counselingThis group will receive both Educational support (Smart booklets) with peer counseling sessions on a monthly basis and mHealth intervention will include daily written and voice reminders, and once weekly an educational led video. | Behavioural | Combined arm |
Primary outcome
Change in systolic blood pressure (SBP)
Time frame: 12- month from baseline
The primary outcome is a change in systolic blood pressure (SBP) of participants at 0, 6, and 12 months. The blood pressure will be recorded by sphygmomanometer used was calibrated upper-arm electronic sphygmomanometer (OMRON HEM-7200, OMRON Corporation, Dalian). Two separate readings will be taken within 5 min, and the average measurement will be the final. If the difference between the two measurements will be more than 5mmHg, then a third recording will be done and the average is considered.
Proportion of participants achieving blood pressure < 140/90 mmHg
Time frame: 12- month from baseline
The proportion of participants achieving the control blood pressure < 140/90 mmHg
Proportion of participants attending scheduled clinic appointments
Time frame: 12- month from baseline
The proportion of participants attending scheduled clinic appointments
1 secondary outcome
Measuring quality of life
Time frame: 12- month from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Background: PubMed 27863813NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017 Jan 7;389(10064):37-55. doi: 10.1016/S0140-6736(16)31919-5. Epub 2016 Nov 16.
- Background: PubMed 12493255Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.
- BackgroundNIPS/Pakistan and ICF NI of PS-. Pakistan Demographic and Health Survey 2017-18. 2019 [cited 4 Jan 2021]. Available: https://dhsprogram.com/publications/publication-fr354-dhs-final-reports.cfm
- Background: PubMed 32021119Mahmood S, Jalal Z, Hadi MA, Orooj H, Shah KU. Non-Adherence to Prescribed Antihypertensives in Primary, Secondary and Tertiary Healthcare Settings in Islamabad, Pakistan: A Cross-Sectional Study. Patient Prefer Adherence. 2020 Jan 14;14:73-85. doi: 10.2147/PPA.S235517. eCollection 2020.
- Background: PubMed 32432556Zhai P, Hayat K, Ji W, Li Q, Shi L, Atif N, Xu S, Li P, Du Q, Fang Y. Efficacy of Text Messaging and Personal Consultation by Pharmacy Students Among Adults With Hypertension: Randomized Controlled Trial. J Med Internet Res. 2020 May 20;22(5):e16019. doi: 10.2196/16019.
- Background: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Background: PubMed 29377058Bhide A, Shah PS, Acharya G. A simplified guide to randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Apr;97(4):380-387. doi: 10.1111/aogs.13309. Epub 2018 Feb 27.
- Background: PubMed 18232619Risser J, Jacobson TA, Kripalani S. Development and psychometric evaluation of the Self-efficacy for Appropriate Medication Use Scale (SEAMS) in low-literacy patients with chronic disease. J Nurs Meas. 2007;15(3):203-19. doi: 10.1891/106137407783095757.
- Background: PubMed 11021874Strobl J, Cave E, Walley T. Data protection legislation: interpretation and barriers to research. BMJ. 2000 Oct 7;321(7265):890-2. doi: 10.1136/bmj.321.7265.890. No abstract available.
- Background: PubMed 24227870Del Re AC, Maisel NC, Blodgett JC, Finney JW. Intention-to-treat analyses and missing data approaches in pharmacotherapy trials for alcohol use disorders. BMJ Open. 2013 Nov 12;3(11):e003464. doi: 10.1136/bmjopen-2013-003464.
- Background: PubMed 14633287Montgomery AA, Peters TJ, Little P. Design, analysis and presentation of factorial randomised controlled trials. BMC Med Res Methodol. 2003 Nov 24;3:26. doi: 10.1186/1471-2288-3-26.
- Background: PubMed 22810445Whelan DB, Dainty K, Chahal J. Efficient designs: factorial randomized trials. J Bone Joint Surg Am. 2012 Jul 18;94 Suppl 1:34-8. doi: 10.2106/JBJS.L.00243.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arshed MUHAMMAD principal investigator
UPM
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational support with peer counseling, mHealth intervention and mHealth intervention and Educational support with peer counseling in people with Treatment Adherence and Compliance, run by Universiti Putra Malaysia at 6 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arshed MUHAMMAD, MBBS,MPH (+923337474464, drarshedchaudhary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure (SBP) (time frame: 12- month from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05106790, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.