Caregiver BurdenYogaNCT05218291
The Effect of Yoga on Care Load, Quality of Life, and Psychological Well-Being of Indivıduals With Special Needs
A study testing Yoga Practice and Ongoing caregivers in people with Caregiver Burden and Quality of Life, run by Maltepe University at 1 site in Turkey (Türkiye).
Trial summary
The fact that an individual has a physical, social or mental disability affects not only the individual, but also the close environment of the individual and even the society in which he lives. Those who are most affected by this situation in the society are undoubtedly the caregivers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Quality of Life, Psychological Stress
- What is being tested?
- Yoga Practice and Ongoing caregivers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2021to 1 May 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between the ages of 18- 65,
- Caring for an individual with special needs,
- Absence of cognitive and physical dysfunction that would prevent doing yoga,
- Agreeing to participate in the study and obtaining consent,
- Having never done yoga before
- Speaking Turkish,
- The caregiver has internet access,
- The caregiver has a computer/tablet/phone with a camera
Who cannot join
- Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga,
- Having had a surgical operation in the last 1 month,
- Not being willing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Technology Applıed Yoga on Care Load, Qualıty of Lıfe, and Psychologıcal Well-Beıng of Indıvıduals Wıth Specıal Needs
The fact that an individual has a physical, social or mental disability affects not only the individual, but also the close environment of the individual and even the society in which he lives. Those who are most affected by this situation in the society are undoubtedly the caregivers. Caregivers of individuals with disabilities experience more anxiety than other caregivers, spare less time for themselves, and participate in less physical and social activities. As a result of social, physical and emotional burdens on parents and other caregivers of disabled individuals, low quality of life, unhealthy family function and negative psychological conditions are observed in caregivers, especially stress. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. The aim of this study; The aim of this study is to examine the effects of technology supported yoga applied to caregivers of individuals with special needs on care burden, quality of life and psychological well-being. Research data will be collected from the caregivers of individuals with special needs registered in a Guidance and Research Center in a province. The data of the study will be collected using the Socio-demographic Data Collection Form, the Caregiver Burden Scale, the Multidimensional Quality of Life Scale, and the Warwick-Edinburgh Mental Well-Being Scale. The study is in a randomized controlled design. SPSS 25.0 program will be used in the data analysis of the research. Descriptive data will be analyzed using number, percentage, mean, standard deviations. Spearman test will be applied to determine the correlations between the scale scores. of groups Homogeneity in terms of descriptive statistics will be analyzed with the Kolmogorov Smirnov Test. Student t or Mann Whitney U tests will be used to compare numerical data in two independent groups, and One-way ANOVA or Kruskal Wallis tests will be used for comparisons in more than two independent groups. Relationships between categorical variables will be tested with chi-square test and relationships between numerical variables will be tested with correlation coefficient. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis.
Read the detailed description
Caregivers mostly consist of parents and even mothers. As primary caregivers in the care of a healthy newborn, mothers experience many physical, emotional and mental problems. Every parent makes plans for their child to be born, their social environment and their own expectations for their children are formed, and therefore, giving birth to a disabled child means that all these planning and expectations are subject to change. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. It has been determined that there are many problems that caregivers experience psychologically, and it is necessary to support caregivers by conducting various interventional studies for these problems. As a result of the researches carried out in the caregivers of the disabled individuals, the existence of negative psychological conditions such as low quality of life, depression and anxiety has been determined and it has been seen that interventional studies are needed in this regard. It has been concluded that yoga has positive effects on other caregivers regarding the problems experienced by caregivers of disabled individuals. This study was planned in accordance with the randomized controlled research design. It will be held between November 2021 and April 2022 with the caregivers of the students registered in the Guidance and Research Centers in Gebze and Darıca Districts of Kocaeli Province. All caregivers between the ages of 18-65 of the students enrolled in the Guidance and Research Centers in Gebze and Darıca Districts in Kocaeli constitute the universe of the research. Using the G Power 3.1.9.4 program, the sample size calculated with a confidence interval of 0.05 and a power of 90% and a large effect size was calculated to be 16 for each group and a total of 32 caregiver studies. It is planned to reach 40 caregivers from each group and 80 caregivers in total, considering the parametric test assumptions and 10% sample loss. Randomization: After filling the pre-test questionnaires with the caregivers who agreed to participate in the research, it will be done by using the SPSS (24.0) statistical package program in the computer environment, taking into account the care burden, quality of life and psychological well-being scale scores. Inclusion Criteria; -Being between the ages of 18- 65, -Caring for a person with special needs for 6 months or more, -Having no physical dysfunction that would prevent doing yoga (COPD, septum deviation, etc.) -Having never done yoga before, -Refused to participate in the study -Speaking Turkish, -The caregiver has internet access, -The caregiver has a computer/tablet with a camera Exclusion criteria; - Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga, - Having had a surgical operation in the last 1 month, - Not being willing to participate in the study. Socio-demographic data and web-based yoga initiative were defined as independent variables. Scale total scores and sub-dimension total scores were defined as dependent variables. Socio-demographic Data Collection Form, Caregiver Burden Scale, Multidimensional Quality of Life Scale and Warwick-Edinburgh Mental Well-Being Scale will be applied to caregivers in the intervention and control groups included in the study. Informed consent will be obtained from caregivers participating in the study.
The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The yoga practice will be applied by the researcher who has a RYT-200 Yoga Alliance yoga instructor certificate over the Zoom application in order to minimize the risk of infection, considering the COVID-19 pandemic period.
The content of the yoga practice consists of the following poses:
-Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose Evaluation of Data: While evaluating the data of the research, descriptive statistics (mean, std. deviation, median, etc.) for numerical variables and frequency distributions for categorical variables will be given. In the study, Kolmogorov Smirnov or Shapiro-Wilk normal distribution test will be used to examine the conformity of the variables to the normal distribution. Demographic data, total scores obtained from the scales in the experimental and control groups will be compared with the chi-square and t test. The difference between the experimental and control groups will be evaluated with an independent two-group t-test. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis
- Conditions
- Caregiver Burden, Quality of Life, Psychological Stress
- Being tested
- Yoga Practice, Ongoing caregivers
- Keywords
- yoga, Caregiver burden, Quality of Life, psychological well-being, individuals with special needs
- Medical subject headings
- Caregiver Burden, Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga PracticeOther
In this study, the yoga initiative to be made for the caregivers in the experimental group consists of breathing, meditation and yoga poses.
Ongoing caregiversOther
Caregivers included in the control group, who did not apply any yoga intervention, will be observed as caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Technology-Supported Yoga Applied Group | Experimental | The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses).
The content of the yoga practice consists of the following poses:
-Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose Receives: Other: Yoga Practice |
| Control Group | Active comparator | No intervention was made in caregivers. Receives: Other: Ongoing caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Burden Scale
The scoring of the 22-item scale is 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) for each item. The total score of the scale ranges from 22 to 88. A maximum of 88 points can be obtained from the scale. The higher the score on the scale, the higher the burden of care is evaluated in the scale.
Measured: at 6 months
Multidimensional Quality of Life Scale (MILQ)
The MILQ questionnaire is a 35-item scale addressing 9 sub-dimensions. The answers in the scale are numbered from 1 to 7. 1 is expressed as "not at all satisfied" and "7" is expressed as "very satisfied". The total score of the scale varies between 35-245. Higher scores represent better functional status.
Measured: at 6 months
Warwick-Edinburgh Mental Well-Being Scale
It consists of 14 items, the scale is in 5-point Likert type and a minimum of 14 and a maximum of 70 points can be obtained from the scale. High scores from the scale indicate high mental (psychological) well-being.
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start15 Nov 2021
- Primary completion1 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maltepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Özdemir, Maltepe University
- Investigators
- Tuğba ÖZDEMİR, PhD, Principal investigator, Maltepe UniversityGülendam KARADAĞ, PhD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218291
- Sponsor's protocol ID
- 55
- Acronym
- Yoga
- Status last verified
- Jun 2022
- First submitted
- 20 Jan 2022
- Last updated
- 9 Jun 2022
- Results posted
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Technology Applıed Yoga on Care Load, Qualıty of Lıfe, and Psychologıcal Well-Beıng of Indıvıduals Wıth Specıal Needs
- ClinicalTrials.gov ID
- NCT05218291
- Acronym / sponsor ID
- Yoga / 55
- Conditions
- Caregiver Burden, Quality of Life, Psychological Stress
- Keywords
- yoga, Caregiver burden, Quality of Life, psychological well-being, individuals with special needs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maltepe UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 1 Feb 2022 (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 fact that an individual has a physical, social or mental disability affects not only the individual, but also the close environment of the individual and even the society in which he lives. Those who are most affected by this situation in the society are undoubtedly the caregivers. Caregivers of individuals with disabilities experience more anxiety than other caregivers, spare less time for themselves, and participate in less physical and social activities. As a result of social, physical and emotional burdens on parents and other caregivers of disabled individuals, low quality of life, unhealthy family function and negative psychological conditions are observed in caregivers, especially stress. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. The aim of this study; The aim of this study is to examine the effects of technology supported yoga applied to caregivers of individuals with special needs on care burden, quality of life and psychological well-being. Research data will be collected from the caregivers of individuals with special needs registered in a Guidance and Research Center in a province. The data of the study will be collected using the Socio-demographic Data Collection Form, the Caregiver Burden Scale, the Multidimensional Quality of Life Scale, and the Warwick-Edinburgh Mental Well-Being Scale. The study is in a randomized controlled design. SPSS 25.0 program will be used in the data analysis of the research. Descriptive data will be analyzed using number, percentage, mean, standard deviations. Spearman test will be applied to determine the correlations between the scale scores. of groups Homogeneity in terms of descriptive statistics will be analyzed with the Kolmogorov Smirnov Test. Student t or Mann Whitney U tests will be used to compare numerical data in two independent groups, and One-way ANOVA or Kruskal Wallis tests will be used for comparisons in more than two independent groups. Relationships between categorical variables will be tested with chi-square test and relationships between numerical variables will be tested with correlation coefficient. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis.
Detailed description
Caregivers mostly consist of parents and even mothers. As primary caregivers in the care of a healthy newborn, mothers experience many physical, emotional and mental problems. Every parent makes plans for their child to be born, their social environment and their own expectations for their children are formed, and therefore, giving birth to a disabled child means that all these planning and expectations are subject to change. Problems related to financial situation, exclusion from social environment, psychological state, sense of burnout and educational status are among the other problems experienced by caregivers. It has been determined that there are many problems that caregivers experience psychologically, and it is necessary to support caregivers by conducting various interventional studies for these problems. As a result of the researches carried out in the caregivers of the disabled individuals, the existence of negative psychological conditions such as low quality of life, depression and anxiety has been determined and it has been seen that interventional studies are needed in this regard. It has been concluded that yoga has positive effects on other caregivers regarding the problems experienced by caregivers of disabled individuals. This study was planned in accordance with the randomized controlled research design. It will be held between November 2021 and April 2022 with the caregivers of the students registered in the Guidance and Research Centers in Gebze and Darıca Districts of Kocaeli Province. All caregivers between the ages of 18-65 of the students enrolled in the Guidance and Research Centers in Gebze and Darıca Districts in Kocaeli constitute the universe of the research. Using the G Power 3.1.9.4 program, the sample size calculated with a confidence interval of 0.05 and a power of 90% and a large effect size was calculated to be 16 for each group and a total of 32 caregiver studies. It is planned to reach 40 caregivers from each group and 80 caregivers in total, considering the parametric test assumptions and 10% sample loss. Randomization: After filling the pre-test questionnaires with the caregivers who agreed to participate in the research, it will be done by using the SPSS (24.0) statistical package program in the computer environment, taking into account the care burden, quality of life and psychological well-being scale scores. Inclusion Criteria; -Being between the ages of 18- 65, -Caring for a person with special needs for 6 months or more, -Having no physical dysfunction that would prevent doing yoga (COPD, septum deviation, etc.) -Having never done yoga before, -Refused to participate in the study -Speaking Turkish, -The caregiver has internet access, -The caregiver has a computer/tablet with a camera Exclusion criteria; - Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga, - Having had a surgical operation in the last 1 month, - Not being willing to participate in the study. Socio-demographic data and web-based yoga initiative were defined as independent variables. Scale total scores and sub-dimension total scores were defined as dependent variables. Socio-demographic Data Collection Form, Caregiver Burden Scale, Multidimensional Quality of Life Scale and Warwick-Edinburgh Mental Well-Being Scale will be applied to caregivers in the intervention and control groups included in the study. Informed consent will be obtained from caregivers participating in the study.
The yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The yoga practice will be applied by the researcher who has a RYT-200 Yoga Alliance yoga instructor certificate over the Zoom application in order to minimize the risk of infection, considering the COVID-19 pandemic period.
The content of the yoga practice consists of the following poses:
-Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose Evaluation of Data: While evaluating the data of the research, descriptive statistics (mean, std. deviation, median, etc.) for numerical variables and frequency distributions for categorical variables will be given. In the study, Kolmogorov Smirnov or Shapiro-Wilk normal distribution test will be used to examine the conformity of the variables to the normal distribution. Demographic data, total scores obtained from the scales in the experimental and control groups will be compared with the chi-square and t test. The difference between the experimental and control groups will be evaluated with an independent two-group t-test. The significance level will be accepted as 0.05. The power and effect size of the study will be calculated by regression analysis
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Technology-Supported Yoga Applied Group | Experimental | Other: Yoga PracticeThe yoga initiative to be applied to the intervention group; Yoga, which is mind-breath-body work; It includes meditation, pranayama (breath work), and asanas (yoga poses). The content of the yoga practice consists of the following poses: -Tadasana (Mountain pose), -Urdhvahastasana, -Uttanasana, -Ardha Uttanasana, -Plank, -Ashtang Pranam, -Bhujangasana (Mini cobra), -Adho Mukha Svanasana (Downward facing dog), -Vrksasana (Tree Pose), - Utthita Trikonasana (Triangle Pose), -Virabhadrasana I (Warrior I), -Virabhadrasana II (Warrior II), -Virabhadrasana I with Anjali Mudra (Hands Reverse Namaste), -Utkatasana (Chair Pose), -Salabhasana, -Paschimottanasana , -Dandasana, -Salamba Sarvangasana (Shoulder pose), -Ardha Urdhva Dhanurasana (Half Wheel Pose), -Reverse Warrior, -Child's pose, -Ananda Balasana (Happy baby), -Wipers, -Corpse Pose |
| Control Group | Active comparator | Other: Ongoing caregiversNo intervention was made in caregivers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Being between the ages of 18- 65,
- Caring for an individual with special needs,
- Absence of cognitive and physical dysfunction that would prevent doing yoga,
- Agreeing to participate in the study and obtaining consent,
- Having never done yoga before
Key exclusion criteria (3 listed)
- Having cognitive and musculoskeletal system, neuromuscular and chronic systemic diseases that prevent doing yoga,
- Having had a surgical operation in the last 1 month,
- Not being willing to participate in the study
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 |
|---|---|---|
| Yoga PracticeIn this study, the yoga initiative to be made for the caregivers in the experimental group consists of breathing, meditation and yoga poses. | Other | Technology-Supported Yoga Applied Group |
| Ongoing caregiversCaregivers included in the control group, who did not apply any yoga intervention, will be observed as caregivers. | Other | Control Group |
Primary outcome
Caregiver Burden Scale
Time frame: at 6 months
The scoring of the 22-item scale is 1 (never), 2 (rarely), 3 (sometimes) and 4 (often) for each item. The total score of the scale ranges from 22 to 88. A maximum of 88 points can be obtained from the scale. The higher the score on the scale, the higher the burden of care is evaluated in the scale.
Multidimensional Quality of Life Scale (MILQ)
Time frame: at 6 months
The MILQ questionnaire is a 35-item scale addressing 9 sub-dimensions. The answers in the scale are numbered from 1 to 7. 1 is expressed as "not at all satisfied" and "7" is expressed as "very satisfied". The total score of the scale varies between 35-245. Higher scores represent better functional status.
Warwick-Edinburgh Mental Well-Being Scale
Time frame: at 6 months
It consists of 14 items, the scale is in 5-point Likert type and a minimum of 14 and a maximum of 70 points can be obtained from the scale. High scores from the scale indicate high mental (psychological) well-being.
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 9 Jun 2022.
- 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.
Tuğba ÖZDEMİR, PhD principal investigator
Maltepe University
Gülendam KARADAĞ, PhD principal investigator
Dokuz Eylul 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 Yoga Practice and Ongoing caregivers in people with Caregiver Burden and Quality of Life, run by Maltepe 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 8 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 9 Jun 2022. 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?
Caregiver Burden Scale (time frame: at 6 months). 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 9 Jun 2022.