LonelinessHELPeNNCT05644288
Impact of the HELPeN Program on Social Isolation in Community-dwelling Elders (HELPeN)
A study testing Help eNursing in people with Loneliness and Isolation, Social, run by MARIA RUZAFA MARTINEZ at 1 site in Spain.
Trial summary
The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Loneliness, Isolation, Social
- What is being tested?
- Help eNursing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 31 Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- score < 32 (Low perceived social support with the DUFSS scale)
- Residence in the community
Who cannot join
- Severe cognitive impairment (8-10 errors on the Pfeiffer test)
- Non Spanish speakers
- Failure to consent to the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Healthcare Area III. Region of Murcia
Lorca, Murcia, 30817
María J Hernández-López, RN, +34968489191, mariaj.hernandez34@carm.es
Solanger Hernández-Méndez, RN, PhD, +34968445792, solanger.hernandez@carm.es
About this study
Official title: Impact of the HELPeN Telecare Program on Social Isolation and Loneliness in Community-dwelling Elders: Randomized Control Trial
The main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs).
Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months.
Read more
Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score <32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group.
The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank.
The control group will not receive any intervention.
- Conditions
- Loneliness, Isolation, Social
- Being tested
- Help eNursing
- Keywords
- Loneliness, Isolation, Social, Elderly people, Telenursing, Volunteers
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Help eNursingOther
The proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program.
The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation.
Over the 36 weeks of the HELPeN Program, each volunteer is expected to provide intervention to 2 seniors, making 1 call per week to each subject lasting approximately 30 minutes. Students will perform physical and psychosocial assessments of the elders and create individualized care plans based on each subject's needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program.
The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation. Receives: Other: Help eNursing |
| Control group | No intervention | No intervention will be performed in the control group and the subjects will be contacted on the same dates as the intervention group for data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness
Name of the measurement: Loneliness
Definition: Loneliness is the result of a cognitive evaluation where there are discrepancies between the social relationships that people desire and those that they really have.
Measuremente tool: UCLA Loniness Scale. Developed by psychologist Daniel Russell (1996), the UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others.
Unit of measure: Indicence of loneliness
Measured: 9 months
Social isolation
Name of the measurement: Social isolation
Definition: Disengagement from social relationships, connections with institutions or community involvement.
Measurement tool: DUKE-UNC Functional Social Support questionnaire(DUFSS). A 14-item, self-administered, multidimensional, functional social support questionnaire.
Unit of measure: Incidence of social isolation
Measured: 9 months
Secondary outcomes (7)
Phisycal function
Name of the measurement: Phisycal function
Definition: The level of functional independence of patients with neuromuscular and musculoskeletal pathologies
Measurement tool: Barthel Index for Activities of Daily Living. Scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.
Unit of measure: % of subjects "able to live independently"; "minimally dependent"; "partially dependent"; "very dependent"; "total dependece"
Measured: 9 months
Depression
Name of the measurment: Depression
Definition: Depression is a common but serious mood disorder. It causes severe symptoms that affect how you feel, think, and handle daily activities, such as sleeping, eating, or working.
Measurement tool: Geriatric Depression Scale (GDS). The original scale consists of 30 dichotomous items (Yes/No), and direct scoring, between 0 and 30.
Unit of measure: Incidence of depression and mean punctuation in the GDS scale
Measured: 9 months
Mental status
Name of the measurement: Mental status
Definition:
Measuremente tool: Short portable mental status questionnaire (SPMSQ) (Pfeiffer's test). It is a brief questionnaire composed of ten questions that measure the degree of cognitive impairment. Evaluates cognitive impairment for the purpose of screening for dementia. Heteroapplied.
Unit of measure: Incidence of cognitive impairment and % of subject with "intact intellectual functioning"; "intact intellectual functioning"; "moderate intellectual impairment" and "severe intellectual impairment"
Measured: 9 months
Anxiety
Name of the measuremente: Anxiety
Definition: Generalized anxiety disorder (GAD) include clearly excessive, uncontrollable, and often irrational anxiety and worry of a duration of at least 6 months
Measuremente tool: 7-item Generalized Anxiety Disorder Scale (GAD-7). It is a 7 items self-report scale designed to identify probable cases of GAD.
Unit of measure: % of subjects with "minimal anxiety"; "mild anxiety"; "severe anxiety"
Measured: 9 months
Health Related Quality of life
Name of the measurement: Health Related Quality of life
Definition: It encompass those aspects of overall quality of life that can be clearly shown to affect health-either physical or mental
Measuremente tool: European Quality of Life-5 Dimension (EQ-5D). It can be used at the individual level to monitor a patient's health status over time. The EQ-5D instrument consists of 2 parts - the EQ-5D descriptive system and the Visual Analog Scale (VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In the VAS the individual scores his or her health between two extremes, 0 and 100, the worst and the best state of health imaginable.
Unit of measure: % of subjects reporting health problems by level in each dimension. Mean punctuation of the VAS scale.
Measured: 9 months
Health assistance
Name of the measurement: Health assistance
Definition: Health care provided to a patient including: hospitalization, face-to-face or telephone consultation, home care, visit to emergency department and the professional providing the care.
Measuremente tool: these information will be collected from electronic record of the patients
Unit of measure:% of subjects requiring health assistance: hospitalization, face-to-face or telephone consultation, home care, visit to emergency department and the professional providing the care.
Measured: 9 months
Drugs
Name of the measurement: Consumption of drugs
Definition: the prescription or increase in daily dosage, according to the anatomical-therapeutic classification (ATC) of the WHO, of the following drugs will be recorded: Psycholeptics, Psychoanaleptics, Analgesics, Muscle relaxants and Other drugs.
Measuremente tool: prescriptions will be collected from electronic record of the patients
Unit of measure: % of subjects taking Psycholeptics, Psychoanaleptics, Analgesics, Muscle relaxants and Other drugs.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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
- Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 9 and 12 months.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MARIA RUZAFA MARTINEZ
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundación Poncemar
- Responsible party
- Sponsor-investigator, MARIA RUZAFA MARTINEZ, Universidad de Murcia
- Investigators
- César Leal-Costa, RN, PhD, Principal investigator, Universidad de MurciaMaría Ruzafa-Martínez, RN, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05644288
- Sponsor's protocol ID
- PI21/00984
- Acronym
- HELPeN
- Status last verified
- Dec 2022
- First submitted
- 26 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the HELPeN Telecare Program on Social Isolation and Loneliness in Community-dwelling Elders: Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05644288
- Acronym / sponsor ID
- HELPeN / PI21/00984
- Conditions
- Loneliness, Isolation, Social
- Keywords
- Loneliness, Isolation, Social, Elderly people, Telenursing, Volunteers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- MARIA RUZAFA MARTINEZUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Fundación Poncemar
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Dec 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 main objective is to determine the effectiveness of the HELPeN Program, a 12-month telephone telenursing program for community-dwelling elderly in social isolation, evaluating the main changes in levels of social isolation, loneliness, quality of life, mental health status (depression), sleep and functional capacity, as well as changes in care management (demand for services and consumption of drugs).
Methodology Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 6, 9 and 12 months.
Participating subjects will be selected by nursing professionals from users of Area 3 of Health of the Region of Murcia over 65 years old, residing in the community and with a Social Isolation score <32 (Low perceived social support with DUFSS). Randomization will be performed after stratification according to whether the subjects live alone or accompanied, with a 1:1 ratio. Given an alpha level of 0.05, an anticipated effect size of 1.58, beta power equal to 1, 42 subjects are required in each group.
The intervention consists of a telephonic telenursing program HELPeN (Help eNursing) to be carried out in collaboration with the Poncemar Volunteer Bank.
The control group will not receive any intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel stratified randomized clinical trial with 12 months duration performing measurements at time 0, 3, 6, 9 and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Help eNursingThe proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program. The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation. |
| Control group | No intervention | –No intervention will be performed in the control group and the subjects will be contacted on the same dates as the intervention group for data collection. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- score < 32 (Low perceived social support with the DUFSS scale)
- Residence in the community
Key exclusion criteria (3 listed)
- Severe cognitive impairment (8-10 errors on the Pfeiffer test)
- Non Spanish speakers
- Failure to consent to 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 |
|---|---|---|
| Help eNursingThe proposed intervention is a telephonic telenursing program aimed at managing social isolation in the elderly, the HELPeN (Help eNursing) program. The operational part of the intervention will be carried out by volunteers nursing students from the University of Murcia enrolled in the academic years 2020-2023. To ensure homogeneity in the intervention carried out by the volunteers they will receive a 15-hour training oriented to ensure the acquisition of essential communication skills for the implementation of the intervention and to know the specific interventions of support and counseling for the elderly in social isolation. Over the 36 weeks of the HELPeN Program, each volunteer is expected to provide intervention to 2 seniors, making 1 call per week to each subject lasting approximately 30 minutes. Students will perform physical and psychosocial assessments of the elders and create individualized care plans based on each subject's needs. | Other | Intervention group |
Primary outcome
Loneliness
Time frame: 9 months
Name of the measurement: Loneliness Definition: Loneliness is the result of a cognitive evaluation where there are discrepancies between the social relationships that people desire and those that they really have. Measuremente tool: UCLA Loniness Scale. Developed by psychologist Daniel Russell (1996), the UCLA Loneliness Scale (Version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Unit of measure: Indicence of loneliness
Social isolation
Time frame: 9 months
Name of the measurement: Social isolation Definition: Disengagement from social relationships, connections with institutions or community involvement. Measurement tool: DUKE-UNC Functional Social Support questionnaire(DUFSS). A 14-item, self-administered, multidimensional, functional social support questionnaire. Unit of measure: Incidence of social isolation
7 secondary outcomes
Phisycal function
Time frame: 9 months
Depression
Time frame: 9 months
Mental status
Time frame: 9 months
Anxiety
Time frame: 9 months
Health Related Quality of life
Time frame: 9 months
Health assistance
Time frame: 9 months
Drugs
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
César Leal-Costa, RN, PhD principal investigator
Universidad de Murcia
María Ruzafa-Martínez, RN, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Help eNursing in people with Loneliness and Isolation, Social, run by MARIA RUZAFA MARTINEZ at 1 site in Spain.
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 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: status not confirmed, as of the sponsor's last update on 9 Dec 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María J Hernández-López, RN, MsC (+34 968489191, mariaj.hernandez34@carm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness (time frame: 9 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 9 Dec 2022.