FAM ACT for Hypertension

1
Effectiveness
1
Safety
Community Health and Social Services Center (CHASS), Detroit, MI
Hypertension+3 More
FAM ACT - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Hypertension

Study Summary

This study is evaluating whether a program which focuses on the family's role in diabetes management may help improve diabetes management.

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Eligible Conditions

  • Hypertension
  • Hyperglycemia
  • Diabetes Mellitus
  • High Blood Pressure (Hypertension)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether FAM ACT will improve 2 primary outcomes and 32 secondary outcomes in patients with Hypertension. Measurement will happen over the course of Baseline vs. 6 months.

Month 12
6-month change in patient glycemic control
Baseline vs. 12 months
12-month change in patient glycemic control
Change from baseline in patient glycemic control at 12 months
Change in SP caregiving burden
Change in SP functional status
Change in depressive and anxiety symptoms in patient
Change in depressive and anxiety symptoms in support person
Change in diabetes self-care behaviors in patient - including diet, exercise, blood sugar testing, and medication taking
Change in diabetes self-care behaviors in support person - including diet and exercise
Change in functional status of patient
Change in number of cigarettes smoked per day (patient)
Change in patient activation in medical visits by patient
Change in patient activation in support person
Change in patient smoking status
Change in self-rated health status of patient
Change in self-rated health status of support person
Baseline vs. 6 months
Change from baseline in patient glycemic control at 6 months
Change in autonomy support - perceived autonomy by the patient for diabetes self- management from support person
Change in diabetes self- care behaviors in patient - including diet, exercise, blood sugar testing, blood pressure checking, foot care and medication taking
Change in diabetes self-care behaviors in patient - including domains of diet, exercise, blood sugar testing, blood pressure checking, foot care and medication taking.
Change in patient BMI
Month 12
Change in autonomy support - perceived autonomy by patient for diabetes self-management from support person
Change in diabetes distress in patient
Change in diabetes distress in support person
Change in diabetes self-care behaviors in patient: Healthy Eating
Change in diabetes self-care behaviors in patient: Medication Adherence
Change in diabetes self-care behaviors in patient: Physical Activity
Change in patient activation in patient
Change in self-efficacy of patient
Change in self-efficacy of support person
Change in systolic blood pressure
Patient perceived overall satisfaction with SP support for diabetes
Patient perception of SP support: Supportive and non-supportive behaviors
Month 12
Impact of COVID on ability to manage diabetes

Trial Safety

Trial Design

2 Treatment Groups

I-DSME + CM
FAM ACT

This trial requires 536 total participants across 2 different treatment groups

This trial involves 2 different treatments. FAM ACT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

FAM ACT
Behavioral
Patient and Support Person (dyad) will be included together as much as possible. The dyad will: Take part in a one-hour introductory session and review of the patient's Diabetes Complications Risk Assessment profile. Be invited to 4-6 Support Person-focused, group diabetes self-management education (DSME) sessions lasting 1-2 ½ hours each. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.
I-DSME + CM
Behavioral
This arm will focus on the patient only. The Support Person assigned to this arm will not be invited to the introduction sessions, care management contacts, or diabetes self-management education sessions. Patients assigned to this arm will: Take part in a one-hour introductory session and review of patient's diabetes management risk assessment. Be invited to 4-6 group diabetes self-management education (DSME) sessions lasting 45 min to 2 hours each. Receive case management contacts with a Community Health Worker (CHW) once every 2-4 weeks, subject to participant availability. Successful contacts will last approximately 20 minutes.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months vs. 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months vs. 12 months for reporting.

Who is running the study

Principal Investigator
A. R.
Prof. Ann-Marie Rosland, Associate Professor
University of Pittsburgh

Closest Location

Community Health and Social Services Center (CHASS) - Detroit, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
HbA1c > 8.0% in the 3 months prior to screening. show original
You must be able to identify a family member or friend who is willing to be involved in their health care. show original
Have a diagnosis of Type 2 diabetes
You plan to use the recruiting site for health care over the next 12 months after enrollment. show original
Patient

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hypertension?

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Hypertension is a common problem in the pediatric emergency department. It is treated with a combination of medical and counseling treatments that vary widely between different institutions. The goals of treatment are to decrease the burden of cardiovascular disease and secondary morbidity and reduce the costs to the pediatric patients and families.

Unverified Answer

What causes hypertension?

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Hypertension is a multifactorial disorder. Factors such as diet, lifestyle and genetics all contribute to its development. In the long term, hypertension can be managed by reducing risk factors including stopping smoking, consuming a low salt diet and exercising regularly.\n

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What are the signs of hypertension?

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Many common signs of hypertension, such as increased pulse in the legs, are frequently noticed for the first time. Most patients, especially males, complain about a sense of heaviness and swelling in the legs. The following signs: dizziness, headaches, and the feeling of cold can be signs of hypertension. The patient must be asked whether the complaint is caused by increased pressure in the arteries supplying the head and neck.

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What is hypertension?

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The following are common symptoms and symptoms when hypertension is present. Fever: Fever can be present when the blood pressure is higher. Chest pain: Chest pain is usually felt during physical activity with higher blood pressure. Nausea, irritability and dizziness: These are common symptoms with high blood pressure. Increased pulse rate (tachycardia): Increased pulse rate is typical of hypertension. Weight loss: People with high blood pressure and kidney problems may experience changes in appetite and body weight. Dizziness: Dizziness is one of the typical symptoms at higher blood pressure. Flushed skin: Flushed skin is seen when blood pressure is too high. High blood glucose: High blood glucose can occur when the blood pressure is high.

Unverified Answer

How many people get hypertension a year in the United States?

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Recent findings suggests that a substantial number of young adults are experiencing hypertension, although there is limited understanding of its cause or management. Health promotion efforts may be effective in preventing hypertension and its consequences.

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Can hypertension be cured?

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Most people with hypertension can maintain lower blood pressures over time by combining one pharmacotherapy with another. These drugs can be taken regularly at the same time without any risk of side effects either during or after the treatment. For most patients with long-standing hypertension and adequate response to these agents, the long-term goal of lowering blood pressure with the least medications is to make the blood pressure low enough that the risks associated with high blood pressure in the absence of symptoms (e.g., stroke, heart attacks, and heart failure) are lowered to the level where preventive health care can be provided. These patients are said to have been cured of their hypertension.

Unverified Answer

Is fam act typically used in combination with any other treatments?

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Combination of famactin with other drugs tends to be used less than one would want. This may be for financial reasons, as the family planning fund expects a family to bear more than two children, making it a financial burden. The benefits of famactin, with and without another drug, are comparable. The main disadvantage is that famactin is very expensive. For a family with monthly expenditures and a small income, there is a significant financial burden.

Unverified Answer

What is the average age someone gets hypertension?

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It is reported there are no national guidelines for the diagnosis of hypertension and for management of that illness, there was the need for standardisation of diagnostic tests for hypertension, use of essential hypertension guideline, and regular follow up of hypertensive patients by their healthcare provider and self-monitoring of the patients. It is found from the study that hypertension is diagnosed earlier to adults from the age of 37 years and up to the age of 65 years.

Unverified Answer

What are the latest developments in fam act for therapeutic use?

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Famact is an efficient, safe and versatile technique, which is more reliable than thiazides or vasodilating drugs (beta-blockers) because of its pharmacokinetic properties and, lastly, its low cost in developing countries.

Unverified Answer

Have there been other clinical trials involving fam act?

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Many clinical trials are not published in peer-reviewed journals, so it is not easy to find a systematic review of all of them. However, the ones we find are often small and of limited applicability, and we recommend a systematic systematic review of all of them.

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Is fam act safe for people?

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Famact can have negative psychological effects and may interfere with people's personal relationships. It should be used with the advice of a health care professional, particularly about the timing and dosage frequency.

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What is the primary cause of hypertension?

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In addition to genetic and environmental factors, psychosocial factors may play a role in the onset of hypertension. Furthermore, a combination of genetic and environmental factors may influence hypertension.

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