Heart FailureMITINCT07721909
"A Nurse-led Motivational Interviewing Tailored Intervention for Improving Self Care Behaviours and Health Outcomes in Heart Failure Patients in Oman
A study testing Motivational interviewing in people with Heart Failure, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
This is a pilot randomized clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteOman
- Study dates
- 1 Jan 2020to 2 Feb 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic adults who are 18 years and older with a heart failure diagnosis --Participants who are able to self-report their experience
- English or Arabic speakers
Who cannot join
- Patients who have a record of cognitive impairment (e.g. Alzheimer's), major psychiatric disorders (e.g. Depression), or concurrent terminal illness (e.g. terminal cancers)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "A Nurse-led Motivational Interviewing Tailored Intervention for Improving Self Care Behaviors and Health Outcomes in Heart Failure Patients in Oman: A Randomized Control Trial"
This is a pilot randomized clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients.
Read the detailed description
This is a pilot randomised clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients. The sample size was 60 patients, 30 participants in each arm. Results from this study will inform the planning for a larger study and on the initiation of a heart failure program to enhance self-care in HF patients. In this study the investigators found that patients were equal in terms of self care at baseline but has improved after the intervention for those who have received the education and follow up. The investigators recommend to initiate heart failure programs in hospitals in Oman to improve health outcomes and reduce the cost of care.
- Conditions
- Heart Failure
- Being tested
- Motivational interviewing, Standard Care (Treatment as Usual)
- Keywords
- Heart failure, oman, motivation, telehealth, nurse
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
this group will receive motivational interviewing and education in addition to telephonic follow up
Standard Care (Treatment as Usual)Other
the patients will get standard care and educational materials
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | This is the control group who will get education materials standard |
| Motivational | Experimental | this group will receive motivational interviewing and education in addition to telephonic follow up Receives: Behavioral: Motivational interviewing; Other: Standard Care (Treatment as Usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Self Care of Heart Failure Index
The Self-Care of Heart Failure Index (SCHFI) Version 6.2) is a validated self-report instrument that measures self-care among individuals with heart failure. It consists of 22 items across three subscales: self-care maintenance (10 items), self-care management (6 items), and self-care confidence (6 items). Scores for each subscale are standardised to a 0-100 scale, with higher scores indicating better self-care. A score of ≥70 is considered indicative of adequate self-care
Measured: At enrolment then at six and nine months
Heart Failure Somatic Perception Scale (HFSPS v.3)
The 18-item Heart Failure Somatic Perception Scale (HFSPS v.3) is a validated self-report instrument that assesses the severity and burden of physical symptoms experienced by individuals with heart failure, such as dyspnea, fatigue, edema, and sleep disturbances. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden and worse symptom perception. Scores are categorised as 0-18 (minimal), 19-36 (mild), 37-54 (moderate), 55-72 (high), and 73-90 (very high) symptom burden.
Measured: At enrolment and then at six and nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Jan 2020
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Al Harrasi, Sultan Qaboos University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721909
- Sponsor's protocol ID
- REF. NO. SQU-EC/029/2020 MREC
- Other IDs
- RC/RG-CON/AHCC/18/01
- Acronym
- MITI
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "A Nurse-led Motivational Interviewing Tailored Intervention for Improving Self Care Behaviors and Health Outcomes in Heart Failure Patients in Oman: A Randomized Control Trial"
- ClinicalTrials.gov ID
- NCT07721909
- Acronym / sponsor ID
- MITI / REF. NO. SQU-EC/029/2020 MREC
- Conditions
- Heart Failure
- Keywords
- Heart failure, oman, motivation, telehealth, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 23 Jul 2026 (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 is a pilot randomized clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients.
Detailed description
This is a pilot randomised clinical trial that have employed a motivational interviewing intervention to enhance self-care in heart failure patients. The sample size was 60 patients, 30 participants in each arm. Results from this study will inform the planning for a larger study and on the initiation of a heart failure program to enhance self-care in HF patients. In this study the investigators found that patients were equal in terms of self care at baseline but has improved after the intervention for those who have received the education and follow up. The investigators recommend to initiate heart failure programs in hospitals in Oman to improve health outcomes and reduce the cost of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –This is the control group who will get education materials standard |
| Motivational | Experimental | Behavioral: Motivational interviewing, Other: Standard Care (Treatment as Usual)this group will receive motivational interviewing and education in addition to telephonic follow up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic adults who are 18 years and older with a heart failure diagnosis --Participants who are able to self-report their experience
- English or Arabic speakers
Key exclusion criteria (1 listed)
- Patients who have a record of cognitive impairment (e.g. Alzheimer's), major psychiatric disorders (e.g. Depression), or concurrent terminal illness (e.g. terminal cancers)
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 |
|---|---|---|
| Motivational interviewingthis group will receive motivational interviewing and education in addition to telephonic follow up | Behavioural | Motivational |
| Standard Care (Treatment as Usual)the patients will get standard care and educational materials | Other | Motivational |
Primary outcome
The Self Care of Heart Failure Index
Time frame: At enrolment then at six and nine months
The Self-Care of Heart Failure Index (SCHFI) Version 6.2) is a validated self-report instrument that measures self-care among individuals with heart failure. It consists of 22 items across three subscales: self-care maintenance (10 items), self-care management (6 items), and self-care confidence (6 items). Scores for each subscale are standardised to a 0-100 scale, with higher scores indicating better self-care. A score of ≥70 is considered indicative of adequate self-care
Heart Failure Somatic Perception Scale (HFSPS v.3)
Time frame: At enrolment and then at six and nine months
The 18-item Heart Failure Somatic Perception Scale (HFSPS v.3) is a validated self-report instrument that assesses the severity and burden of physical symptoms experienced by individuals with heart failure, such as dyspnea, fatigue, edema, and sleep disturbances. The total score ranges from 0 to 90, with higher scores indicating greater symptom burden and worse symptom perception. Scores are categorised as 0-18 (minimal), 19-36 (mild), 37-54 (moderate), 55-72 (high), and 73-90 (very high) symptom burden.
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 23 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Heart Failure, run by Sultan Qaboos University at 1 site in Oman.
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 2 inclusion and 1 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 23 Jul 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 Oman. 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?
The Self Care of Heart Failure Index (time frame: At enrolment then at six and nine months). The study lists 2 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 23 Jul 2026.