HypertensionPUSH-MENCT03442257
Text Message Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension
A study testing SMS in people with Hypertension and Cardiovascular Risk Factor, run by Lund University at 3 sites in Sweden.
Trial summary
The primary objective of the study is to examine the impact of lifestyle advices, administered through regularly sent SMS, on hypertension in a primary health care setting. The secondary objective is to evaluate changes in other cardiovascular risk factors and general health, e.g. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factor
- What is being tested?
- SMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 3 sitesSweden
- Study dates
- 19 Mar 2018to 18 Dec 2018
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9).
- 40 to 80 years of age
- Patient must own a mobile phone compatible with SMS
Who cannot join
- History of myocardial infarction, stroke, transient ischemic attack (TIA), claudicatio intermittens, abdominal aortic aneurysm, previous heart surgery i.e. PCI or bypass (reported by recruiting physician or by patient in the questionnaire)
- Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure <120 mmHg.
- Serious illness, other than cardiovascular, with short life expectancy (<1 year)
- Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Löddeköpinge vårdcentral
Löddeköpinge, Skåne County, 24630
Lomma vårdcentral
Lomma, Skåne County, 23434
Sorgenfri vårdcentral
Malmö, Skåne County, 214 33
About this study
Official title: PUSH ME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension: a Randomized Controlled Pilot Trial
The primary objective of the study is to examine the impact of lifestyle advices, administered through regularly sent SMS, on hypertension in a primary health care setting. The secondary objective is to evaluate changes in other cardiovascular risk factors and general health, e.g. tobacco use, obesity, blood lipids, blood glucose, self-rated health and health-related quality of life.
Read the detailed description
Background- The globalization of unhealthy lifestyles and demographic ageing of the world's population has contributed to the fact that high blood pressure is classified by World Health Organization as the world's leading risk for mortality.
Persistent hypertension is a key risk factor for coronary heart disease (CHD), stroke and other cardiovascular diseases (CVD), such as heart failure. CVD is, despite a decline in recent decades, still the leading cause of death in Sweden (4). The prevalence of hypertension in adults is around 40% according to a recent multinational study (5). In 30-40% of hypertensive individuals, additional metabolic risk factors such as dyslipidemia, insulin resistance and elevated glucose occur simultaneously, which further multiply the risk for heart disease, diabetes and stroke. An unhealthy lifestyle with physical inactivity and excess energy intake is the major driver of these metabolic risk factors. In most cases lifestyle intervention can reverse or reduce the unfavorable metabolic profile.
Primary healthcare in Sweden is managing the first-line healthcare, offering both prevention and treatment for a majority of chronic diseases. In Sweden, the vast majority of patients with hypertension are treated in primary health care. If the hypertension is well controlled, the GP typically meets the patient once a year for medical checkup, blood tests and medical prescription.
Interventions by SMS-texting have been shown to significantly improve compliance to medications, follow-up rate or disease monitoring.
Trial Design - Randomised clinical trial
Intervention - The experimental treatment will consist of an SMS-intervention addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension.
After baseline measurement participants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
Control Treatment - The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
Recruitment - The participants will be recruited consecutively from three different PHCCs in Skåne. Patients with hypertension will receive information about the study at their annual check-up or other appointment with their GP. If they choose to participate, they will be contacted by phone by a research assistant for additional information, possibility to ask questions about the study, and scheduling a baseline control at their PHCC.
Baseline examination - Included patients that consent to take part in the study will be invited to their PHCC for a baseline visit. The following measurements will be assessed by a research assistant: blood pressure (in sitting position after 5 minutes rest; mean of two measurements in a standardized procedure with validated electronic BP devices), BMI and waist-hip circumference. Furthermore, the patients will complete a short questionnaire for evaluation of medical history, medication, tobacco and alcohol use, physical activity level, self-rated health and health-related quality of life. Blood samples for fasting plasma glucose, HbA1c and cholesterol will be drawn in the morning within a few days after the baseline visit.
Randomization- Randomization to study groups will be performed after completion of baseline assessments and questionnaires. A computer generated random number schedule with block sizes of four will be prepared. To assure allocation concealment, the information about group affiliation will be delivered through sealed envelopes.
The research assistant, the patients' GPs, as well as all researchers except Magnus Sandberg (MS) will be blinded to group allocation. If the patients have questions regarding the SMS function they will be able to contact MS for help.
Follow up- Follow up control will be performed after 6 months with the same assessments as at the baseline visit.
Power and sample size - For the pilot study we have assumed that a total number of 60 patients (20 patients per PHCC) will be sufficient to evaluate the feasibility of the intervention and the logistics of the assessments.
For the future full scale study, each group must contain 143 participants. The sample size is based on an assumed statistical power of 80 %, a two-sided test, a significance level of 5 %, a difference of 5 mm Hg between the groups, a standard deviation of 14 mm Hg and a drop out rate of 15 %.
Analysis plan - Data will be analysed according to the Intention-to-treat principle. Differences in mean change of end points between intervention and control groups will be calculated by ANCOVA, with baseline values as covariates.
- Conditions
- Hypertension, Cardiovascular Risk Factor
- Being tested
- SMS
- Keywords
- Hypertension, Text Messaging, Primary Prevention, Cardiovascular Risk Factor, Primary Health Care, Health Promotion
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMSBehavioural
The experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. Participants will receive four semi-personalized messages per week in addition to their usual care. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
| Study group | Role | What they receive |
|---|---|---|
| SMS group | Experimental | Participants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. Receives: Behavioral: SMS |
| Control | No intervention | The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure
Measured by automated devices (mmHg)
Measured: Six months
Secondary outcomes (10)
Changes in cholesterol
Measured by blood test, total cholesterol (mmol/l)
Measured: six months
Changes in high-density lipoprotein [HDL]
Measured by blood test, high-density lipoprotein [HDL] (mmol/l)
Measured: six months
Changes in low-density lipoprotein [LDL]
Measured by blood test, low-density lipoprotein [LDL] (mmol/l)
Measured: six months
Changes in tobacco use
Self-reported
Measured: six months
Changes in BMI
Measured by research assistant at baseline and follow up (weight and hight will be combined to report BMI in kg/m2)
Measured: six months
Changes in Blood glucose
HbA1c
Measured: six months
Changes in self-rated health
five-graded Likert scale from excellent to poor. The question posed is; in general, would you say that you health is excellent, very good, good, fair, or poor?
Measured: six months
Changes in self rated quality of life
EQ5D-5L (EuroQol 5 dimentions).The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: six months
Changes in level of physical activity
self-reported physical activity
Measured: six months
Changes in alcohol use
self-reported
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start19 Mar 2018
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442257
- Sponsor's protocol ID
- 2017/674
- Acronym
- PUSH-ME
- Status last verified
- Feb 2018
- First submitted
- 11 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 27863813Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
PubMed 24002282Schillaci G, Pirro M, Vaudo G, Gemelli F, Marchesi S, Porcellati C, Mannarino E. Prognostic value of the metabolic syndrome in essential hypertension. J Am Coll Cardiol. 2004 May 19;43(10):1817-22. doi: 10.1016/j.jacc.2003.12.049.
PubMed 15145106Grundy SM. Metabolic syndrome update. Trends Cardiovasc Med. 2016 May;26(4):364-73. doi: 10.1016/j.tcm.2015.10.004. Epub 2015 Oct 31.
PubMed 26654259Lin H, Wu X. Intervention strategies for improving patient adherence to follow-up in the era of mobile information technology: a systematic review and meta-analysis. PLoS One. 2014 Aug 6;9(8):e104266. doi: 10.1371/journal.pone.0104266. eCollection 2014.
PubMed 25100267Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
PubMed 19382860Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
PubMed 26456490Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945.
PubMed 26393848Wolff M, Sundquist K, Larsson Lonn S, Midlov P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.
PubMed 24314119Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
PubMed 11701584
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PUSH ME (Primary Care USage of Health Promoting Messages): A Text Message-based Intervention for Prevention of Cardiovascular Disease in Primary Care Patients With Hypertension: a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03442257
- Acronym / sponsor ID
- PUSH-ME / 2017/674
- Conditions
- Hypertension, Cardiovascular Risk Factor
- Keywords
- Hypertension, Text Messaging, Primary Prevention, Cardiovascular Risk Factor, Primary Health Care, Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 19 Mar 2018 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 22 Feb 2018 (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.
The primary objective of the study is to examine the impact of lifestyle advices, administered through regularly sent SMS, on hypertension in a primary health care setting. The secondary objective is to evaluate changes in other cardiovascular risk factors and general health, e.g. tobacco use, obesity, blood lipids, blood glucose, self-rated health and health-related quality of life.
Detailed description
Background- The globalization of unhealthy lifestyles and demographic ageing of the world's population has contributed to the fact that high blood pressure is classified by World Health Organization as the world's leading risk for mortality.
Persistent hypertension is a key risk factor for coronary heart disease (CHD), stroke and other cardiovascular diseases (CVD), such as heart failure. CVD is, despite a decline in recent decades, still the leading cause of death in Sweden (4). The prevalence of hypertension in adults is around 40% according to a recent multinational study (5). In 30-40% of hypertensive individuals, additional metabolic risk factors such as dyslipidemia, insulin resistance and elevated glucose occur simultaneously, which further multiply the risk for heart disease, diabetes and stroke. An unhealthy lifestyle with physical inactivity and excess energy intake is the major driver of these metabolic risk factors. In most cases lifestyle intervention can reverse or reduce the unfavorable metabolic profile.
Primary healthcare in Sweden is managing the first-line healthcare, offering both prevention and treatment for a majority of chronic diseases. In Sweden, the vast majority of patients with hypertension are treated in primary health care. If the hypertension is well controlled, the GP typically meets the patient once a year for medical checkup, blood tests and medical prescription.
Interventions by SMS-texting have been shown to significantly improve compliance to medications, follow-up rate or disease monitoring.
Trial Design - Randomised clinical trial
Intervention - The experimental treatment will consist of an SMS-intervention addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension.
After baseline measurement participants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
Control Treatment - The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment.
Recruitment - The participants will be recruited consecutively from three different PHCCs in Skåne. Patients with hypertension will receive information about the study at their annual check-up or other appointment with their GP. If they choose to participate, they will be contacted by phone by a research assistant for additional information, possibility to ask questions about the study, and scheduling a baseline control at their PHCC.
Baseline examination - Included patients that consent to take part in the study will be invited to their PHCC for a baseline visit. The following measurements will be assessed by a research assistant: blood pressure (in sitting position after 5 minutes rest; mean of two measurements in a standardized procedure with validated electronic BP devices), BMI and waist-hip circumference. Furthermore, the patients will complete a short questionnaire for evaluation of medical history, medication, tobacco and alcohol use, physical activity level, self-rated health and health-related quality of life. Blood samples for fasting plasma glucose, HbA1c and cholesterol will be drawn in the morning within a few days after the baseline visit.
Randomization- Randomization to study groups will be performed after completion of baseline assessments and questionnaires. A computer generated random number schedule with block sizes of four will be prepared. To assure allocation concealment, the information about group affiliation will be delivered through sealed envelopes.
The research assistant, the patients' GPs, as well as all researchers except Magnus Sandberg (MS) will be blinded to group allocation. If the patients have questions regarding the SMS function they will be able to contact MS for help.
Follow up- Follow up control will be performed after 6 months with the same assessments as at the baseline visit.
Power and sample size - For the pilot study we have assumed that a total number of 60 patients (20 patients per PHCC) will be sufficient to evaluate the feasibility of the intervention and the logistics of the assessments.
For the future full scale study, each group must contain 143 participants. The sample size is based on an assumed statistical power of 80 %, a two-sided test, a significance level of 5 %, a difference of 5 mm Hg between the groups, a standard deviation of 14 mm Hg and a drop out rate of 15 %.
Analysis plan - Data will be analysed according to the Intention-to-treat principle. Differences in mean change of end points between intervention and control groups will be calculated by ANCOVA, with baseline values as covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| SMS group | Experimental | Behavioral: SMSParticipants in the intervention group will receive four semi-personalized messages per week in addition to their usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. |
| Control | No intervention | –The control group will receive usual care according to the National Board of Health and Welfare guidelines for hypertension treatment. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with hypertension (defined by the International classification of disease Manual ICD-10, diagnose code I10.9).
- 40 to 80 years of age
- Patient must own a mobile phone compatible with SMS
Key exclusion criteria (4 listed)
- History of myocardial infarction, stroke, transient ischemic attack (TIA), claudicatio intermittens, abdominal aortic aneurysm, previous heart surgery i.e. PCI or bypass (reported by recruiting physician or by patient in the questionnaire)
- Blood pressure at baseline visit ≥180/110 mmHg or systolic blood pressure <120 mmHg.
- Serious illness, other than cardiovascular, with short life expectancy (<1 year)
- Predicted inability to comply with the study protocol e.g. language difficulties, interpreter needs, serious cognitive impairment.
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 |
|---|---|---|
| SMSThe experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. Participants will receive four semi-personalized messages per week in addition to their usual care. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet. | Behavioural | SMS group |
Primary outcome
Change in blood pressure
Time frame: Six months
Measured by automated devices (mmHg)
10 secondary outcomes
Changes in cholesterol
Time frame: six months
Changes in high-density lipoprotein [HDL]
Time frame: six months
Changes in low-density lipoprotein [LDL]
Time frame: six months
Changes in tobacco use
Time frame: six months
Changes in BMI
Time frame: six months
Changes in Blood glucose
Time frame: six months
Changes in self-rated health
Time frame: six months
Changes in self rated quality of life
Time frame: six months
Changes in level of physical activity
Time frame: six months
Changes in alcohol use
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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 24002282Chow CK, Teo KK, Rangarajan S, Islam S, Gupta R, Avezum A, Bahonar A, Chifamba J, Dagenais G, Diaz R, Kazmi K, Lanas F, Wei L, Lopez-Jaramillo P, Fanghong L, Ismail NH, Puoane T, Rosengren A, Szuba A, Temizhan A, Wielgosz A, Yusuf R, Yusufali A, McKee M, Liu L, Mony P, Yusuf S; PURE (Prospective Urban Rural Epidemiology) Study investigators. Prevalence, awareness, treatment, and control of hypertension in rural and urban communities in high-, middle-, and low-income countries. JAMA. 2013 Sep 4;310(9):959-68. doi: 10.1001/jama.2013.184182.
- Background: PubMed 15145106Schillaci G, Pirro M, Vaudo G, Gemelli F, Marchesi S, Porcellati C, Mannarino E. Prognostic value of the metabolic syndrome in essential hypertension. J Am Coll Cardiol. 2004 May 19;43(10):1817-22. doi: 10.1016/j.jacc.2003.12.049.
- Background: PubMed 26654259Grundy SM. Metabolic syndrome update. Trends Cardiovasc Med. 2016 May;26(4):364-73. doi: 10.1016/j.tcm.2015.10.004. Epub 2015 Oct 31.
- Background: PubMed 25100267Lin H, Wu X. Intervention strategies for improving patient adherence to follow-up in the era of mobile information technology: a systematic review and meta-analysis. PLoS One. 2014 Aug 6;9(8):e104266. doi: 10.1371/journal.pone.0104266. eCollection 2014.
- Background: PubMed 19382860Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099.
- Background: PubMed 26456490Bengtsson U, Kjellgren K, Hallberg I, Lindwall M, Taft C. Improved Blood Pressure Control Using an Interactive Mobile Phone Support System. J Clin Hypertens (Greenwich). 2016 Feb;18(2):101-8. doi: 10.1111/jch.12682. Epub 2015 Oct 12.
- Background: PubMed 26393848Chow CK, Redfern J, Hillis GS, Thakkar J, Santo K, Hackett ML, Jan S, Graves N, de Keizer L, Barry T, Bompoint S, Stepien S, Whittaker R, Rodgers A, Thiagalingam A. Effect of Lifestyle-Focused Text Messaging on Risk Factor Modification in Patients With Coronary Heart Disease: A Randomized Clinical Trial. JAMA. 2015 Sep 22-29;314(12):1255-63. doi: 10.1001/jama.2015.10945.
- Background: PubMed 24314119Wolff M, Sundquist K, Larsson Lonn S, Midlov P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.
- Background: PubMed 11701584Vickers AJ, Altman DG. Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ. 2001 Nov 10;323(7321):1123-4. doi: 10.1136/bmj.323.7321.1123. No abstract available.
- Council MR. Developing and evaluating complex interventions: new guidance 2008Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS in people with Hypertension and Cardiovascular Risk Factor, run by Lund University at 3 sites in Sweden.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure (time frame: Six months). 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 NCT03442257, which also lists 10 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 15 Feb 2019.