Heart FailureNCT07017751
Pender HPM-Based Online Education and Telephone Follow-Up in Adults With Heart Failure
A study testing HPM-Based Online Education and Telephone Follow-Up in people with Heart Failure, run by Naile ALANKAYA at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial evaluated the effects of Pender's Health Promotion Model (HPM)-based structured online education combined with planned telephone follow-up on heart failure symptom burden, heart failure-related dietary behaviors, and medication adherence among adults with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HPM-Based Online Education and Telephone Follow-Up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 30 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Having a cardiologist-confirmed diagnosis of heart failure.
- Having access to the technological resources required for online participation (smartphone, tablet, or computer with internet access).
- Being literate and able to read, understand, and write in Turkish.
- Providing written informed consent to participate in the study.
Who cannot join
- Having severe cognitive impairment or an active psychiatric illness that could interfere with participation in the study.
- Having severe visual, hearing, or speech impairment that could prevent effective communication and participation in the intervention.
- Being on a heart transplantation waiting list or having recently undergone heart transplantation and being under post-transplant follow-up.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Merkez, Çanakkale, 17100
About this study
Official title: Effects of Pender's Health Promotion Model-Based Online Education and Telephone Follow-Up on Symptom Burden, Dietary Behaviors, and Medication Adherence in Adults With Heart Failure: A Randomized Controlled Trial
This randomized controlled trial evaluated the effects of Pender's Health Promotion Model (HPM)-based structured online education combined with planned telephone follow-up on heart failure symptom burden, heart failure-related dietary behaviors, and medication adherence among adults with heart failure. Sixty participants were randomly allocated in a 1:1 ratio to an intervention group or a control group. The intervention group received routine clinical care plus individualized synchronous online education and two planned telephone reinforcement contacts, whereas the control group received routine clinical care. The three primary outcomes were assessed at baseline and 2 months after baseline.
Read the detailed description
Heart failure (HF) is a chronic condition that requires sustained self-management, including symptom monitoring, adherence to dietary recommendations, and appropriate medication-taking behaviors. Structured education and continued support may facilitate these behaviors by addressing individual barriers, perceived benefits, self-efficacy, motivation, and available support resources. Pender's Health Promotion Model (HPM) provides a theoretical framework for structuring such interventions.
This randomized controlled trial evaluated the effects of Pender's HPM-based structured online education combined with planned telephone follow-up on HF symptom burden, HF-related dietary behaviors, and medication adherence among adults with HF.
The sample size was determined a priori using G*Power version 3.1.9.7. Based on an alpha level of 0.05, an effect size of 1.128, and 95% statistical power, the minimum required sample size was 44 participants (22 per group). To allow for potential attrition during follow-up, the target sample size was increased to 60 participants (30 per group).
A total of 60 participants were randomly allocated in a 1:1 ratio to the intervention group (n = 30) or control group (n = 30). Baseline assessments were completed before group allocation.
Participants allocated to the intervention group continued to receive routine clinical care and additionally received an individually delivered, synchronous online educational intervention structured according to Pender's HPM. The education was delivered via WhatsApp or Google Meet in a single session lasting approximately 25-30 minutes. The educational content addressed HF-related dietary behaviors, symptom management, and medication adherence and incorporated HPM constructs including perceived benefits and barriers, self-efficacy, motivation and readiness for change, and available support resources. Digital educational materials were provided after the session. Participants also received two planned telephone follow-up calls approximately 2 weeks and 1 month after the educational session for individualized clarification and reinforcement of the educational content.
Participants allocated to the control group continued to receive routine clinical care and did not receive the structured HPM-based online education or planned telephone follow-up from the research team during the study period. Routine clinical care could include information or counseling provided by physicians or nurses as part of usual clinical practice; however, such care was neither delivered nor standardized by the research team. After completion of the final outcome assessment, participants were provided with a printed version of the educational material used in the intervention group.
The three primary outcomes were HF symptom burden, HF-related dietary behaviors, and medication adherence. These outcomes were assessed using the Heart Failure Symptom Status Scale (HFSSS), Heart Failure Dietary Behavior Scale (HFDBS), and 7-item Adherence to Refills and Medications Scale (ARMS-7), respectively. All three outcomes were assessed at baseline and 2 months after baseline.
- Conditions
- Heart Failure
- Being tested
- HPM-Based Online Education and Telephone Follow-Up
- Keywords
- Symptom Burden, Medication Adherence, Dietary Behavior, Pender's Health Promotion Model, Online Education
- Medical subject headings
- Heart Failure, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPM-Based Online Education and Telephone Follow-UpOther
Also called Heart Failure Self-Management Education
An individually delivered, synchronous online educational intervention structured according to Pender's Health Promotion Model, followed by two planned telephone reinforcement contacts approximately 2 weeks and 1 month after the education. The intervention addressed heart failure-related dietary behaviors, symptom management, and medication adherence and was provided in addition to routine clinical care. The educational session lasted approximately 25-30 minutes and was delivered via WhatsApp or Google Meet. Digital educational materials were provided after the session.
| Study group | Role | What they receive |
|---|---|---|
| Intervetion group | Experimental | Participants allocated to the intervention group received routine clinical care plus an individually delivered, synchronous online educational intervention structured according to Pender's Health Promotion Model. The education was delivered via WhatsApp or Google Meet in a single session lasting approximately 25-30 minutes and addressed heart failure-related dietary behaviors, symptom management, and medication adherence. Participants also received two planned telephone follow-up calls approximately 2 weeks and 1 month after the educational session for individualized clarification and reinforcement of the educational content. Outcomes were assessed at baseline and 2 months after baseline. Receives: Other: HPM-Based Online Education and Telephone Follow-Up |
| Control group | No intervention | Participants allocated to the control group continued to receive routine clinical care and did not receive the structured HPM-based online education or planned telephone follow-up from the research team during the study period. Routine care could include information or counseling provided by physicians or nurses as part of usual clinical practice; however, such care was neither delivered nor standardized by the research team. Outcomes were assessed at baseline and 2 months after baseline. After completion of the final outcome assessment, participants were provided with a printed version of the educational material used in the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure Symptom Status Scale (HFSSS)
Heart failure symptom burden is assessed using the Heart Failure Symptom Status Scale (HFSSS). The total score ranges from 0 to 84, with higher scores indicating greater heart failure symptom burden.
Measured: Baseline and 2 months after baseline
7-item Adherence to Refills and Medications Scale (ARMS-7)
Medication adherence is assessed using the 7-item Adherence to Refills and Medications Scale (ARMS-7). The scale comprises two subscales: medication adherence (4 items; score range, 4-16) and prescription refill (3 items; score range, 3-12). Item 7 is reverse-scored. The total score ranges from 7 to 28, with lower scores indicating better medication adherence.
Measured: Baseline and 2 months after baseline
Heart Failure Dietary Behavior Scale (HFDBS)
Heart failure-related dietary behaviors are assessed using the 19-item Heart Failure Dietary Behavior Scale (HFDBS). The total score ranges from 19 to 76, with higher scores indicating better adherence to recommended heart failure-related dietary behaviors.
Measured: Baseline and 2 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Dec 2025
- Primary completion15 Feb 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naile ALANKAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naile ALANKAYA, Çanakkale Onsekiz Mart University
- Investigators
- NAİLE ALANKAYA, Assoc. Prof, Study director, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017751
- Sponsor's protocol ID
- COMU-SBF-NA-02
- Status last verified
- Oct 2026
- First submitted
- 4 Jun 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to privacy and ethical considerations related to participant data. De-identified data supporting the findings of the study may be available from the corresponding author upon reasonable request, subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pender's Health Promotion Model-Based Online Education and Telephone Follow-Up on Symptom Burden, Dietary Behaviors, and Medication Adherence in Adults With Heart Failure: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07017751
- Acronym / sponsor ID
- COMU-SBF-NA-02
- Conditions
- Heart Failure
- Keywords
- Symptom Burden, Medication Adherence, Dietary Behavior, Pender's Health Promotion Model, Online Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Naile ALANKAYAUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 12 Jun 2025 (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.
This randomized controlled trial evaluated the effects of Pender's Health Promotion Model (HPM)-based structured online education combined with planned telephone follow-up on heart failure symptom burden, heart failure-related dietary behaviors, and medication adherence among adults with heart failure. Sixty participants were randomly allocated in a 1:1 ratio to an intervention group or a control group. The intervention group received routine clinical care plus individualized synchronous online education and two planned telephone reinforcement contacts, whereas the control group received routine clinical care. The three primary outcomes were assessed at baseline and 2 months after baseline.
Detailed description
Heart failure (HF) is a chronic condition that requires sustained self-management, including symptom monitoring, adherence to dietary recommendations, and appropriate medication-taking behaviors. Structured education and continued support may facilitate these behaviors by addressing individual barriers, perceived benefits, self-efficacy, motivation, and available support resources. Pender's Health Promotion Model (HPM) provides a theoretical framework for structuring such interventions.
This randomized controlled trial evaluated the effects of Pender's HPM-based structured online education combined with planned telephone follow-up on HF symptom burden, HF-related dietary behaviors, and medication adherence among adults with HF.
The sample size was determined a priori using G*Power version 3.1.9.7. Based on an alpha level of 0.05, an effect size of 1.128, and 95% statistical power, the minimum required sample size was 44 participants (22 per group). To allow for potential attrition during follow-up, the target sample size was increased to 60 participants (30 per group).
A total of 60 participants were randomly allocated in a 1:1 ratio to the intervention group (n = 30) or control group (n = 30). Baseline assessments were completed before group allocation.
Participants allocated to the intervention group continued to receive routine clinical care and additionally received an individually delivered, synchronous online educational intervention structured according to Pender's HPM. The education was delivered via WhatsApp or Google Meet in a single session lasting approximately 25-30 minutes. The educational content addressed HF-related dietary behaviors, symptom management, and medication adherence and incorporated HPM constructs including perceived benefits and barriers, self-efficacy, motivation and readiness for change, and available support resources. Digital educational materials were provided after the session. Participants also received two planned telephone follow-up calls approximately 2 weeks and 1 month after the educational session for individualized clarification and reinforcement of the educational content.
Participants allocated to the control group continued to receive routine clinical care and did not receive the structured HPM-based online education or planned telephone follow-up from the research team during the study period. Routine clinical care could include information or counseling provided by physicians or nurses as part of usual clinical practice; however, such care was neither delivered nor standardized by the research team. After completion of the final outcome assessment, participants were provided with a printed version of the educational material used in the intervention group.
The three primary outcomes were HF symptom burden, HF-related dietary behaviors, and medication adherence. These outcomes were assessed using the Heart Failure Symptom Status Scale (HFSSS), Heart Failure Dietary Behavior Scale (HFDBS), and 7-item Adherence to Refills and Medications Scale (ARMS-7), respectively. All three outcomes were assessed at baseline and 2 months after baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervetion group | Experimental | Other: HPM-Based Online Education and Telephone Follow-UpParticipants allocated to the intervention group received routine clinical care plus an individually delivered, synchronous online educational intervention structured according to Pender's Health Promotion Model. The education was delivered via WhatsApp or Google Meet in a single session lasting approximately 25-30 minutes and addressed heart failure-related dietary behaviors, symptom management, and medication adherence. Participants also received two planned telephone follow-up calls approximately 2 weeks and 1 month after the educational session for individualized clarification and reinforcement of the educational content. Outcomes were assessed at baseline and 2 months after baseline. |
| Control group | No intervention | –Participants allocated to the control group continued to receive routine clinical care and did not receive the structured HPM-based online education or planned telephone follow-up from the research team during the study period. Routine care could include information or counseling provided by physicians or nurses as part of usual clinical practice; however, such care was neither delivered nor standardized by the research team. Outcomes were assessed at baseline and 2 months after baseline. After completion of the final outcome assessment, participants were provided with a printed version of the educational material used in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older.
- Having a cardiologist-confirmed diagnosis of heart failure.
- Having access to the technological resources required for online participation (smartphone, tablet, or computer with internet access).
- Being literate and able to read, understand, and write in Turkish.
- Providing written informed consent to participate in the study.
Key exclusion criteria (3 listed)
- Having severe cognitive impairment or an active psychiatric illness that could interfere with participation in the study.
- Having severe visual, hearing, or speech impairment that could prevent effective communication and participation in the intervention.
- Being on a heart transplantation waiting list or having recently undergone heart transplantation and being under post-transplant follow-up.
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 |
|---|---|---|
| HPM-Based Online Education and Telephone Follow-UpAlso: Heart Failure Self-Management EducationAn individually delivered, synchronous online educational intervention structured according to Pender's Health Promotion Model, followed by two planned telephone reinforcement contacts approximately 2 weeks and 1 month after the education. The intervention addressed heart failure-related dietary behaviors, symptom management, and medication adherence and was provided in addition to routine clinical care. The educational session lasted approximately 25-30 minutes and was delivered via WhatsApp or Google Meet. Digital educational materials were provided after the session. | Other | Intervetion group |
Primary outcome
Heart Failure Symptom Status Scale (HFSSS)
Time frame: Baseline and 2 months after baseline
Heart failure symptom burden is assessed using the Heart Failure Symptom Status Scale (HFSSS). The total score ranges from 0 to 84, with higher scores indicating greater heart failure symptom burden.
7-item Adherence to Refills and Medications Scale (ARMS-7)
Time frame: Baseline and 2 months after baseline
Medication adherence is assessed using the 7-item Adherence to Refills and Medications Scale (ARMS-7). The scale comprises two subscales: medication adherence (4 items; score range, 4-16) and prescription refill (3 items; score range, 3-12). Item 7 is reverse-scored. The total score ranges from 7 to 28, with lower scores indicating better medication adherence.
Heart Failure Dietary Behavior Scale (HFDBS)
Time frame: Baseline and 2 months after baseline
Heart failure-related dietary behaviors are assessed using the 19-item Heart Failure Dietary Behavior Scale (HFDBS). The total score ranges from 19 to 76, with higher scores indicating better adherence to recommended heart failure-related dietary behaviors.
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to privacy and ethical considerations related to participant data. De-identified data supporting the findings of the study may be available from the corresponding author upon reasonable request, subject to applicable ethical and institutional requirements.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
NAİLE ALANKAYA, Assoc. Prof study director
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPM-Based Online Education and Telephone Follow-Up in people with Heart Failure, run by Naile ALANKAYA at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Heart Failure Symptom Status Scale (HFSSS) (time frame: Baseline and 2 months after 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?
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 7 Oct 2026.