Tele-nursingNCT05863338
The Effect of Nursing Follow-Up by Phone on The Self-Efficacy,Pain,Disease Activity in Rheumatoid Arthritis Patients
A study testing NURSING FOLLOW-UP BY PHONE in people with Tele-nursing, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to determine the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. The study sample consisted of 64 individuals, including 32 interventions and 32 comparison groups, who met the inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Tele-nursing
- What is being tested?
- NURSING FOLLOW-UP BY PHONE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 1 Jul 2021
- 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 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having been diagnosed with rheumatoid arthritis for at least 1 year,
- To have received at least 3 doses of biologic agent subcutaneously within the DMARD combination treatment option,
- Not having problems in communicating,
- Having no mental problems, hearing and vision problems,
- Being 18 years or older,
- Being conscious,
Show all 10Show fewer
- Being able to communicate by phone,
- Applying to Sivas Numune Hospital Rheumatology Polyclinic,
- No planned training by health professionals on RA and biological agent therapy before,
- Agree to participate in the study.
Who cannot join
- Losing one's life during the research period,
- Termination of biological agent treatment for any reason,
- Leaving the research voluntarily.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nursing Follow-Up by Phone on the Self-Efficacy, Pain and Disease Activity Level of Individuals Diagnosed With Rheumatoid Arthritis Using Biological Agents
The aim of this study was to determine the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. The study sample consisted of 64 individuals, including 32 interventions and 32 comparison groups, who met the inclusion criteria. The research was conducted in a randomized controlled experimental study design. In data collection; 'Personal Information Form', 'Arthritis Self-Efficacy Scale', 'Visual Analog Scale' and 'DAS 28' score was used. Descriptive statistics (mean±sd) for numerical variables and frequency distributions for categorical variables were used to evaluate the data.
Individuals in the intervention group participating in the research; 65.6% of them were women and their mean age was 50.12 (±13.200); of the individuals in the comparison group who participated in the study, it was determined that 56.3% of them were female, their mean age was 45.97 (±11.544). There was no difference in self- efficacy, pain, and disease activity in the first evaluation before the nursing follow-up by phone between the individuals in the intervention and comparison group, and as a result of the 24-week nursing follow-up by phone of the individuals in the intervention group after the training, when compared with the individuals in the comparison group who received routine outpatient service; It was noted that there was an increase in self- efficacy, a decrease in pain severity, and a decrease in disease activity.
The self-efficacy, pain, and disease activity of individuals with a diagnosis of RA who use biological agents should be monitored regularly, training needs should be met, telenursing counseling practices should be expanded to increase the effectiveness of education and to manage the process more effectively, and arrangements should be made to enable patients to access telenursing counseling.
Read the detailed description
The study was conducted in a randomized controlled experimental study design with the aim of determining the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. After the power analysis to calculate the sample size of the study, a total of 64 patients were included in each group with 80% power and 5% margin of error assuming that a minimum difference of 2 points was clinically significant in pairwise comparisons made according to VAS pain scores. In the research, patients who applied nursing follow-up by phone formed the intervention group, and patients who only received routine care formed the control group.
- Conditions
- Tele-nursing
- Being tested
- NURSING FOLLOW-UP BY PHONE
- Keywords
- Rheumatoid Arthritis, Biological Agent, Telephone Monitoring, Nursing Practices
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NURSING FOLLOW-UP BY PHONEBehavioural
The training was carried out in the form of individual training and as a single session.The training,which lasted about 30 minutes,was carried out in the training room of the polyclinic with the support of Barco vision.In the training session,lecture,question-answer methods were used and at the end of the training session,a booklet containing the training content was given to the patients.The researcher phoned the patients once a week for 24 weeks,conveyed how they were doing,whether there was anything they wanted to ask or learn,and provided counseling to the patients in line with their needs.The next week's plan was also determined in the phone calls made in the following weeks.Patient follow-ups as stated were continued for 24 weeks.At the 12th and 24th weeks of the telephone nursing follow-up, the patients filled out the scales again.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Data collection tools were applied face to face. Patient education was carried out in the polyclinic. A training booklet was given at the end of the training. Afterwards, patients were called once a week by telephone for 12 weeks. The patients were followed up by the nurse over the phone and counseling was provided to the patients. Patients were able to call the research nurse when needed. Interim evaluation was made at the 12th week. Data collection tools were applied face-to-face in the outpatient clinic. Patients 13-24. Between weeks, 12 more phone calls were made, once a week. The patients were followed up by the nurse by telephone, and the patients continued to receive counseling services. Patients were able to call the research nurse when needed. At the end of the 24th week, the research forms were applied face to face in the outpatient clinic. The research has finished. Receives: Behavioral: NURSING FOLLOW-UP BY PHONE |
| Control Group | No intervention | Individuals meeting the sample specifications were included in the control group in accordance with the order of numbers in the lists created by randomly assigning numbers. Data collection tools were applied face to face. Routine outpatient follow-ups continued. Interim evaluation was made at the 12th week. In the interim evaluation, data collection tools were applied face to face. Then, routine outpatient follow-up between 13 and 24 weeks continued. At the end of the 24th week, data collection tools were applied face to face. The patients were educated in the outpatient clinic. A training booklet was given at the end of the training. The research has been terminated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis Self-Efficacy Scale
It was developed in the United States in 1989 by Lorig et al. to help individuals cope with their arthritis and to measure their self-efficacy perceptions. There are a total of 20 expressions on the 10-digit visual scale, which has 3 sub-scopes: self-efficacy in pain, self-efficacy in functions, and self-efficacy in other symptoms. Turkish validity and reliability study was carried out by Ünsal and Kaşıkçı in 2006.
Measured: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Arthritis Self-Efficacy scores at the end of the 12th and 24th weeks
Secondary outcomes (2)
Pain Visual Analog Scale -VAS
It is used to convert some values that cannot be expressed through numbers into numeric. Pain experienced by the patient during use in RA; Absence of pain is graded between 0 points and severe pain is scored between 10 points (Gift, 1989).
Measured: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Pain Visual Analog scores at the end of the 12th and 24th weeks
DAS-28 (Disease Activity Score 28)
It is a scoring system used to determine rheumatoid arthritis disease activity. The calculation is routinely performed by the physician for all patients by evaluating the number of tender and swollen joints, erythrocyte sedimentation rate, global evaluation of the patient and VAS measurements in a special type calculator. According to the obtained DAS score; DAS 28 ≤2.4 is considered as remission, 2.4-3.6 low disease activity, 3.6-5.5 moderate disease activity, ≥ 5.5 high activity value (Prevoo et al., 1995).
Measured: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline DAS-28 (Disease Activity Score 28) scores at the end of the 12th and 24th weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Sep 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Tele-nursingStudies 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
- Model description
- The study was conducted as the randomized controlled experimental trial.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Done Gunay, Cumhuriyet University
- Investigators
- Hatice Tel Aydın, Professor, Study director, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05863338
- Sponsor's protocol ID
- 2020-06/38
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Gronning K, Lim S, Bratas O. Health status and self-management in patients with inflammatory arthritis-A five-year follow-up study after nurse-led patient education. Nurs Open. 2019 Oct 8;7(1):326-333. doi: 10.1002/nop2.394. eCollection 2020 Jan.
PubMed 31871717Mollard E, Michaud K. Self-Management of Rheumatoid Arthritis: Mobile Applications. Curr Rheumatol Rep. 2020 Nov 26;23(1):2. doi: 10.1007/s11926-020-00968-7.
PubMed 33244621Piga M, Cangemi I, Mathieu A, Cauli A. Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda. Semin Arthritis Rheum. 2017 Aug;47(1):121-128. doi: 10.1016/j.semarthrit.2017.03.014. Epub 2017 Mar 22.
PubMed 28420491Primdahl J, Sorensen J, Horn HC, Petersen R, Horslev-Petersen K. Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial. Ann Rheum Dis. 2014 Feb;73(2):357-64. doi: 10.1136/annrheumdis-2012-202695. Epub 2013 Feb 5.
PubMed 23385306Ryan S. Psychological effects of living with rheumatoid arthritis. Nurs Stand. 2014 Dec 2;29(13):52-9. doi: 10.7748/ns.29.13.52.e9484.
PubMed 25424112Uthman I, Almoallim H, Buckley CD, Masri B, Dahou-Makhloufi C, El Dershaby Y, Sunna N, Raza K, Kumar K, Abu-Saad Huijer H, Tashkandi N, Louw I, Adelowo O. Nurse-led care for the management of rheumatoid arthritis: a review of the global literature and proposed strategies for implementation in Africa and the Middle East. Rheumatol Int. 2021 Mar;41(3):529-542. doi: 10.1007/s00296-020-04682-6. Epub 2020 Aug 26.
PubMed 32851423Zhang L, Cai P, Zhu W. Depression has an impact on disease activity and health-related quality of life in rheumatoid arthritis: A systematic review and meta-analysis. Int J Rheum Dis. 2020 Mar;23(3):285-293. doi: 10.1111/1756-185X.13774. Epub 2019 Dec 19.
PubMed 31858731
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nursing Follow-Up by Phone on the Self-Efficacy, Pain and Disease Activity Level of Individuals Diagnosed With Rheumatoid Arthritis Using Biological Agents
- ClinicalTrials.gov ID
- NCT05863338
- Acronym / sponsor ID
- 2020-06/38
- Conditions
- Tele-nursing
- Keywords
- Rheumatoid Arthritis, Biological Agent, Telephone Monitoring, Nursing Practices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 18 May 2023 (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 aim of this study was to determine the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. The study sample consisted of 64 individuals, including 32 interventions and 32 comparison groups, who met the inclusion criteria. The research was conducted in a randomized controlled experimental study design. In data collection; 'Personal Information Form', 'Arthritis Self-Efficacy Scale', 'Visual Analog Scale' and 'DAS 28' score was used. Descriptive statistics (mean±sd) for numerical variables and frequency distributions for categorical variables were used to evaluate the data.
Individuals in the intervention group participating in the research; 65.6% of them were women and their mean age was 50.12 (±13.200); of the individuals in the comparison group who participated in the study, it was determined that 56.3% of them were female, their mean age was 45.97 (±11.544). There was no difference in self- efficacy, pain, and disease activity in the first evaluation before the nursing follow-up by phone between the individuals in the intervention and comparison group, and as a result of the 24-week nursing follow-up by phone of the individuals in the intervention group after the training, when compared with the individuals in the comparison group who received routine outpatient service; It was noted that there was an increase in self- efficacy, a decrease in pain severity, and a decrease in disease activity.
The self-efficacy, pain, and disease activity of individuals with a diagnosis of RA who use biological agents should be monitored regularly, training needs should be met, telenursing counseling practices should be expanded to increase the effectiveness of education and to manage the process more effectively, and arrangements should be made to enable patients to access telenursing counseling.
Detailed description
The study was conducted in a randomized controlled experimental study design with the aim of determining the effect of nursing follow-up by phone on the self-efficacy status, pain, and disease activity of individuals with RA using biological agents. After the power analysis to calculate the sample size of the study, a total of 64 patients were included in each group with 80% power and 5% margin of error assuming that a minimum difference of 2 points was clinically significant in pairwise comparisons made according to VAS pain scores. In the research, patients who applied nursing follow-up by phone formed the intervention group, and patients who only received routine care formed the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was conducted as the randomized controlled experimental trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: NURSING FOLLOW-UP BY PHONEData collection tools were applied face to face. Patient education was carried out in the polyclinic. A training booklet was given at the end of the training. Afterwards, patients were called once a week by telephone for 12 weeks. The patients were followed up by the nurse over the phone and counseling was provided to the patients. Patients were able to call the research nurse when needed. Interim evaluation was made at the 12th week. Data collection tools were applied face-to-face in the outpatient clinic. Patients 13-24. Between weeks, 12 more phone calls were made, once a week. The patients were followed up by the nurse by telephone, and the patients continued to receive counseling services. Patients were able to call the research nurse when needed. At the end of the 24th week, the research forms were applied face to face in the outpatient clinic. The research has finished. |
| Control Group | No intervention | –Individuals meeting the sample specifications were included in the control group in accordance with the order of numbers in the lists created by randomly assigning numbers. Data collection tools were applied face to face. Routine outpatient follow-ups continued. Interim evaluation was made at the 12th week. In the interim evaluation, data collection tools were applied face to face. Then, routine outpatient follow-up between 13 and 24 weeks continued. At the end of the 24th week, data collection tools were applied face to face. The patients were educated in the outpatient clinic. A training booklet was given at the end of the training. The research has been terminated. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Having been diagnosed with rheumatoid arthritis for at least 1 year,
- To have received at least 3 doses of biologic agent subcutaneously within the DMARD combination treatment option,
- Not having problems in communicating,
- Having no mental problems, hearing and vision problems,
- Being 18 years or older,
Key exclusion criteria (3 listed)
- Losing one's life during the research period,
- Termination of biological agent treatment for any reason,
- Leaving the research voluntarily.
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 |
|---|---|---|
| NURSING FOLLOW-UP BY PHONEThe training was carried out in the form of individual training and as a single session.The training,which lasted about 30 minutes,was carried out in the training room of the polyclinic with the support of Barco vision.In the training session,lecture,question-answer methods were used and at the end of the training session,a booklet containing the training content was given to the patients.The researcher phoned the patients once a week for 24 weeks,conveyed how they were doing,whether there was anything they wanted to ask or learn,and provided counseling to the patients in line with their needs.The next week's plan was also determined in the phone calls made in the following weeks.Patient follow-ups as stated were continued for 24 weeks.At the 12th and 24th weeks of the telephone nursing follow-up, the patients filled out the scales again. | Behavioural | Intervention Group |
Primary outcome
Arthritis Self-Efficacy Scale
Time frame: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Arthritis Self-Efficacy scores at the end of the 12th and 24th weeks
It was developed in the United States in 1989 by Lorig et al. to help individuals cope with their arthritis and to measure their self-efficacy perceptions. There are a total of 20 expressions on the 10-digit visual scale, which has 3 sub-scopes: self-efficacy in pain, self-efficacy in functions, and self-efficacy in other symptoms. Turkish validity and reliability study was carried out by Ünsal and Kaşıkçı in 2006.
2 secondary outcomes
Pain Visual Analog Scale -VAS
Time frame: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Pain Visual Analog scores at the end of the 12th and 24th weeks
DAS-28 (Disease Activity Score 28)
Time frame: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline DAS-28 (Disease Activity Score 28) scores at the end of the 12th and 24th weeks
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 18 May 2023.
- Background: PubMed 31871717Gronning K, Lim S, Bratas O. Health status and self-management in patients with inflammatory arthritis-A five-year follow-up study after nurse-led patient education. Nurs Open. 2019 Oct 8;7(1):326-333. doi: 10.1002/nop2.394. eCollection 2020 Jan.
- Background: PubMed 33244621Mollard E, Michaud K. Self-Management of Rheumatoid Arthritis: Mobile Applications. Curr Rheumatol Rep. 2020 Nov 26;23(1):2. doi: 10.1007/s11926-020-00968-7.
- Background: PubMed 28420491Piga M, Cangemi I, Mathieu A, Cauli A. Telemedicine for patients with rheumatic diseases: Systematic review and proposal for research agenda. Semin Arthritis Rheum. 2017 Aug;47(1):121-128. doi: 10.1016/j.semarthrit.2017.03.014. Epub 2017 Mar 22.
- Background: PubMed 23385306Primdahl J, Sorensen J, Horn HC, Petersen R, Horslev-Petersen K. Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial. Ann Rheum Dis. 2014 Feb;73(2):357-64. doi: 10.1136/annrheumdis-2012-202695. Epub 2013 Feb 5.
- Background: PubMed 25424112Ryan S. Psychological effects of living with rheumatoid arthritis. Nurs Stand. 2014 Dec 2;29(13):52-9. doi: 10.7748/ns.29.13.52.e9484.
- Background: PubMed 32851423Uthman I, Almoallim H, Buckley CD, Masri B, Dahou-Makhloufi C, El Dershaby Y, Sunna N, Raza K, Kumar K, Abu-Saad Huijer H, Tashkandi N, Louw I, Adelowo O. Nurse-led care for the management of rheumatoid arthritis: a review of the global literature and proposed strategies for implementation in Africa and the Middle East. Rheumatol Int. 2021 Mar;41(3):529-542. doi: 10.1007/s00296-020-04682-6. Epub 2020 Aug 26.
- Background: PubMed 31858731Zhang L, Cai P, Zhu W. Depression has an impact on disease activity and health-related quality of life in rheumatoid arthritis: A systematic review and meta-analysis. Int J Rheum Dis. 2020 Mar;23(3):285-293. doi: 10.1111/1756-185X.13774. Epub 2019 Dec 19.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
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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.
Hatice Tel Aydın, Professor study director
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NURSING FOLLOW-UP BY PHONE in people with Tele-nursing, run by Cumhuriyet University 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 10 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 18 May 2023. 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?
Arthritis Self-Efficacy Scale (time frame: It was administered at the first interview and at 12 and 24 weeks after the completion of the training. Changes from baseline Arthritis Self-Efficacy scores at the end of the 12th and 24th weeks). 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 NCT05863338, which also lists 7 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 18 May 2023.