HPL Program for Geriatric Patients' at Risk for Stroke

December 3, 2022 updated by: TA Shoulkamy, Assiut University

Health Promoting Lifestyle Program for Geriatric Patients' at Risk for Stroke

Stroke is a highest reason of illness and death all over world. In 2017, stroke was the second greatest recurrent reason of mortality, after ischemic cardiac illness, and produced 6.2 million mortality all over world. The load of stroke does not only lie in the great mortality but the great morbidity also results in up to 50% of survivors being chronically disabled. Thus stroke is a disease of huge public health importance with economic and social consequences.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with stroke with uncontrolled glucose levels have higher mortality and poor post stroke outcomes. Controlling diabetes and other associated risk factors are effective ways to prevent initial strokes as well as stroke recurrence. Diabetes increases ischemic stroke incidence in all age groups, individuals with diabetes are more likely to suffer from hypertension, myocardial infarction and high cholesterol than individuals without diabetes have been linked to a greater risk of stroke. Smoking is a major cause of cardiovascular disease and causes one of every four deaths from cardiovascular disease. Smoking can raise triglycerides (a type of fat in your blood), Lower "good" cholesterol (high-density lipoprotein), Make blood sticky and more likely to clot, which can block blood flow to the heart and brain, Damage cells that line the blood vessels, Increase the buildup of plaque (fat, cholesterol, calcium, and other substances) in blood vessels and cause thickening and narrowing of blood vessels.The idea of lifestyle includes a broad variety of subjects, containing substantial life, spiritual life and other issues. Physical activity, smoking, alcohol consumption, nutrition and other aspects to measure lifestyle used by Chinese scientists. Health promoting lifestyle (HPL) is defined as "a multi-dimensional pattern of self-initiated actions and perceptions that serve to maintain or enhance the level of wellness, self-actualization, and fulfillment of the individual". It assesses a personal well-being activity that involves physical activity, dieting, spiritual growth, interpersonal relationships, health responsibility, and stress management, and would lead to enhaning wellbeing condition

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Faculty of nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 60 years and more
  • Diagnosed with hypertension, diabetes mellitus and cardiac diseases.
  • Able to communicate with health team, free from mental problems, and agreed to participate in the study were included.

Exclusion Criteria:

  • unable to communicate with health team.
  • free from mental problems.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Educational program
aged patients 60 years and more, able to communicate, diagnosed with hypertension, diabetes mellitus and cardiac diseases. they will receive the nursing educational program which will be implemented in small groups from (5-7) in outpatient clinics. It includes nutrition, exercise, control hypertension , engage in weight control measures, smoking cessation, stress management, breathing exercise, appropriate treatment of diseases, control of diabetes, control of cholesterol in blood and routine follow up).also they will receive health-promoting lifestyle that includes (spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility and stress management).
Behavioral: educational program
The nursing educational program will be implemented in small groups from (5-7) in outpatient clinics. It includes nutrition, exercise, control hypertension , engage in weight control measures, smoking cessation, stress management, breathing exercise, appropriate treatment of diseases, control of diabetes, control of cholesterol in blood and routine follow up).
No Intervention: control group
aged patients 60 years and more, able to communicate, diagnosed with hypertension, diabetes mellitus and cardiac diseases. the will not receive educational program and life style promotion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the effect of implementing nursing educational program on Health Promoting Lifestyle for geriatric patients' at risk for stroke.
Time Frame: 3 months
by using tool II: It is a well-established instrument to assess personal lifestyle behaviors that promote health. It is composed of a 52-items questionnaire that is answered according to a 4-point Likert-type scale, with (Never (N) = 1, Sometimes (S) = 2, Often (O) = 3, Routinely (R) = 4). The total scale is 52-items and composed of six subscales to measure dimensions of health-promoting lifestyle that includes (spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility and stress management). The total score will be adjusted from 0 to 100 and can classify the result to good lifestyle behavior if the percent score 60% and more and bad lifestyle behavior if less than 60%.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 16, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2022

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HPLgeriatric

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings