Health Status DisparitiesAEQUALISNCT02733523
Self-management, Health Literacy and Social Capital in Socioeconomically Disadvantaged Older Adults
A study testing Program "Sentirnos bien" (Feeling well) in people with Health Status Disparities and Subjective Health, run by Fundacio Salut i Envelliment UAB.
Trial summary
Motivations: Socio-economic and education determinants have a big impact on health outcomes, in terms of worse health status in populations living in more disadvantaged conditions. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Status Disparities, Subjective Health, Self Care
- What is being tested?
- Program "Sentirnos bien" (Feeling well)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2017
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- community-dwelling older adults living in the urban areas of Barcelona, Blanes or Reus in socio-economically disadvantaged neighbourhoods.
- perception of their health as regular or bad according to the first question of the 12 items Short Form Survey from the RAND Medical Outcomes Study.
Who cannot join
- dependency to go to the local primary care center
- cognitive decline or dementia as diagnose
- any health condition that contraindicates physical activity
- terminal illness
- severe mental health disorders that difficult participating in a group dynamic
About this study
Official title: Promoting Self-Management, Health Literacy And Social Capital In Socioeconomically Disadvantaged Older Adults To Reduce Later Life Health Inequalities: A Randomized Clinical Trial
Motivations:
Socio-economic and education determinants have a big impact on health outcomes, in terms of worse health status in populations living in more disadvantaged conditions. Social capital, self-management and health literacy are some of the intermediate determinants, with the potential to mitigate health inequalities through interventions driven by local health agents. These three determinants are intensely interlinked and have, separately, impacts on self-perceived health. Social capital is defined in this project as an umbrella concept, which includes quantitative aspects of social resources (structural social capital: social networks and contacts, social and civic participation) as well as qualitative or subjective aspects (cognitive social capital: perceived social support, feeling of belonging and trust) and covers relations between subjects at a micro or individual level (family and friends) as well as at a macro or community level. Health literacy is understood as cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Both are key aspects for self-management behaviours. The target of our research project are older people living in urban socioeconomically disadvantaged areas, since ageing is in itself an inequality axis and urban environments concentrate the highest health disparities.
Read more
Objectives: With the aim to reduce health inequality, an intervention has been designed to promote self-management, health literacy and social capital among older people who perceived their health as fair or poor and are living in urban socioeconomically disadvantaged areas with the aim of improving their self-perceived health. Secondarily, the efficacy of the intervention will be analysed in terms of increasing self-management, health literacy and social capital (social support and social participation), quality of life, mental health and healthy lifestyles.
In third place, behavioural health patterns will be identified in relation to health literacy, social capital, gender, socioeconomic and educational level, and they will be linked to the intervention efficacy levels.
- Conditions
- Health Status Disparities, Subjective Health, Self Care, Social Capital, Health Literacy, Aging
- Being tested
- Program "Sentirnos bien" (Feeling well)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program "Sentirnos bien" (Feeling well)Behavioural
Group-based intervention delivered face-to face and held once a week during 3 months. It comprises:
- Promoting the uptake of self-care healthy habits: providing information, setting personal goals and sharing experiences to facilitate behavioural change, specially on physical activity and healthy dietary habits.
- Promoting social capital at individual level: facilitating mutual knowledge and mutual support among participants and fostering participation in sociocultural and community activities in the neighbourhood through visits to the community assets accompanied by volunteers.
- Promoting health literacy: improving navigation through the health care system, communication with health professionals, as well as the understanding and decision making when buying food.
| Study group | Role | What they receive |
|---|---|---|
| Program "Sentirnos bien" | Experimental | The intervention Program "Sentirnos bien" is based around a group dynamic, held once a week during 3 months, aimed at:
1. Promoting the uptake of self-care healthy habits
2. Promoting social capital at individual level:
3. Promoting health literacy Receives: Behavioral: Program "Sentirnos bien" (Feeling well) |
| Control arm | No intervention | The control arm will receive no intervention. Once the trial is finished, i.e. after the last follow-up evaluation, this arm will receive the intervention (waiting-list approach). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-perceived health
Same question than the 12 items Short Form Survey from the RAND Medical Outcomes Study. Answers will be recategorized as positive perception (excellent, very good or good) vs negative (regular or bad)
Measured: at 3 months (just after the intervention)
Secondary outcomes (14)
Self-perceived health
Thermometer from 0-100
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health related quality of life
12 items Short Form Survey from the RAND Medical Outcomes Study.
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-rated quality of life
Thermometer from 0-100
Measured: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Loneliness
Scale Gierveld and De Jong
Measured: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Depressive symptoms
Geriatric Depression Scale
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Physical activity
International Physical Activity Questionnaire (IPAQ)
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Short Physical Performance Battery
Functional test that scores performance in three physical aspects: balance, strength and gait speed.
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health service use
Times attending primary and hospital health care
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Unintended effects
Questions ad hoc to assess effects not intended by the intervention perceived negatively by the participant.
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-care / healthy habits
Scale ASA (Appraisal of Self-Care Agency Scale)
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health literacy
questions from the European Health Literacy Scale (HLS EU-16)
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social capital
2 questions from the European Values Survey
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social support
Questionnaire "Inventario de recursos sociales en ancianos" from Díaz Veiga
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social participation
Questionnaire "Escala Este II de Soledad - Índice de participación social subjetiva"
Measured: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Health Status DisparitiesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Salut i Envelliment UAB
- Sponsor type
- University, hospital or other
- Collaborators
- Recercaixa, Equip Atencio Primaria Sardenya
- Responsible party
- Principal investigator, Laura Coll, Fundacio Salut i Envelliment UAB
- Investigators
- Laura Coll-Planas, MD, Principal investigator, Fundació Salut i Envelliment UABSergi Blancafort, PhD, Principal investigator, Fundació Salut i Envelliment UABRosa Monteserin, MD PhD, Principal investigator, Equipo Atencio Primaria Sardenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733523
- Sponsor's protocol ID
- FSIE-Recercaixa2014
- Acronym
- AEQUALIS
- Status last verified
- Feb 2018
- First submitted
- 10 Feb 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
PubMed 21768583Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005108. doi: 10.1002/14651858.CD005108.pub2.
PubMed 17943839Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.
PubMed 15047786Ahnquist J, Wamala SP, Lindstrom M. Social determinants of health--a question of social or economic capital? Interaction effects of socioeconomic factors on health outcomes. Soc Sci Med. 2012 Mar;74(6):930-9. doi: 10.1016/j.socscimed.2011.11.026. Epub 2012 Jan 21.
PubMed 22305807Kawachi I, Kennedy BP, Glass R. Social capital and self-rated health: a contextual analysis. Am J Public Health. 1999 Aug;89(8):1187-93. doi: 10.2105/ajph.89.8.1187.
PubMed 10432904Nyqvist F, Forsman AK, Giuntoli G, Cattan M. Social capital as a resource for mental well-being in older people: a systematic review. Aging Ment Health. 2013;17(4):394-410. doi: 10.1080/13607863.2012.742490. Epub 2012 Nov 27.
PubMed 23186534Blancafort Alias S, Monteserin Nadal R, Moral I, Roque Figols M, Rojano I Luque X, Coll-Planas L. Promoting social capital, self-management and health literacy in older adults through a group-based intervention delivered in low-income urban areas: results of the randomized trial AEQUALIS. BMC Public Health. 2021 Jan 7;21(1):84. doi: 10.1186/s12889-020-10094-9.
PubMed 33413233Coll-Planas L, Blancafort S, Rojano X, Roque M, Monteserin R. Promoting self-management, health literacy and social capital to reduce health inequalities in older adults living in urban disadvantaged areas: protocol of the randomised controlled trial AEQUALIS. BMC Public Health. 2018 Mar 13;18(1):345. doi: 10.1186/s12889-018-5219-x.
PubMed 29534699
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Self-Management, Health Literacy And Social Capital In Socioeconomically Disadvantaged Older Adults To Reduce Later Life Health Inequalities: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02733523
- Acronym / sponsor ID
- AEQUALIS / FSIE-Recercaixa2014
- Conditions
- Health Status Disparities, Subjective Health, Self Care, Social Capital, Health Literacy, Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Fundacio Salut i Envelliment UABUniversity, hospital or other
- Collaborators
- Recercaixa, Equip Atencio Primaria Sardenya
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2017 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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.
Motivations:
Socio-economic and education determinants have a big impact on health outcomes, in terms of worse health status in populations living in more disadvantaged conditions. Social capital, self-management and health literacy are some of the intermediate determinants, with the potential to mitigate health inequalities through interventions driven by local health agents. These three determinants are intensely interlinked and have, separately, impacts on self-perceived health. Social capital is defined in this project as an umbrella concept, which includes quantitative aspects of social resources (structural social capital: social networks and contacts, social and civic participation) as well as qualitative or subjective aspects (cognitive social capital: perceived social support, feeling of belonging and trust) and covers relations between subjects at a micro or individual level (family and friends) as well as at a macro or community level. Health literacy is understood as cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand and use information in ways which promote and maintain good health. Both are key aspects for self-management behaviours. The target of our research project are older people living in urban socioeconomically disadvantaged areas, since ageing is in itself an inequality axis and urban environments concentrate the highest health disparities.
Objectives: With the aim to reduce health inequality, an intervention has been designed to promote self-management, health literacy and social capital among older people who perceived their health as fair or poor and are living in urban socioeconomically disadvantaged areas with the aim of improving their self-perceived health. Secondarily, the efficacy of the intervention will be analysed in terms of increasing self-management, health literacy and social capital (social support and social participation), quality of life, mental health and healthy lifestyles.
In third place, behavioural health patterns will be identified in relation to health literacy, social capital, gender, socioeconomic and educational level, and they will be linked to the intervention efficacy levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Program "Sentirnos bien" | Experimental | Behavioral: Program "Sentirnos bien" (Feeling well)The intervention Program "Sentirnos bien" is based around a group dynamic, held once a week during 3 months, aimed at: 1. Promoting the uptake of self-care healthy habits 2. Promoting social capital at individual level: 3. Promoting health literacy |
| Control arm | No intervention | –The control arm will receive no intervention. Once the trial is finished, i.e. after the last follow-up evaluation, this arm will receive the intervention (waiting-list approach). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- community-dwelling older adults living in the urban areas of Barcelona, Blanes or Reus in socio-economically disadvantaged neighbourhoods.
- perception of their health as regular or bad according to the first question of the 12 items Short Form Survey from the RAND Medical Outcomes Study.
Key exclusion criteria (5 listed)
- dependency to go to the local primary care center
- cognitive decline or dementia as diagnose
- any health condition that contraindicates physical activity
- terminal illness
- severe mental health disorders that difficult participating in a group dynamic
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 |
|---|---|---|
| Program "Sentirnos bien" (Feeling well)Group-based intervention delivered face-to face and held once a week during 3 months. It comprises: 1. Promoting the uptake of self-care healthy habits: providing information, setting personal goals and sharing experiences to facilitate behavioural change, specially on physical activity and healthy dietary habits. 2. Promoting social capital at individual level: facilitating mutual knowledge and mutual support among participants and fostering participation in sociocultural and community activities in the neighbourhood through visits to the community assets accompanied by volunteers. 3. Promoting health literacy: improving navigation through the health care system, communication with health professionals, as well as the understanding and decision making when buying food. | Behavioural | Program "Sentirnos bien" |
Primary outcome
Self-perceived health
Time frame: at 3 months (just after the intervention)
Same question than the 12 items Short Form Survey from the RAND Medical Outcomes Study. Answers will be recategorized as positive perception (excellent, very good or good) vs negative (regular or bad)
14 secondary outcomes
Self-perceived health
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health related quality of life
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-rated quality of life
Time frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Loneliness
Time frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Depressive symptoms
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Physical activity
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Short Physical Performance Battery
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health service use
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Unintended effects
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Self-care / healthy habits
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Health literacy
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social capital
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social support
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Social participation
Time frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Background: PubMed 21768583Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005.
- Background: PubMed 17943839Foster G, Taylor SJ, Eldridge SE, Ramsay J, Griffiths CJ. Self-management education programmes by lay leaders for people with chronic conditions. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005108. doi: 10.1002/14651858.CD005108.pub2.
- Background: PubMed 15047786Fried LP, Carlson MC, Freedman M, Frick KD, Glass TA, Hill J, McGill S, Rebok GW, Seeman T, Tielsch J, Wasik BA, Zeger S. A social model for health promotion for an aging population: initial evidence on the Experience Corps model. J Urban Health. 2004 Mar;81(1):64-78. doi: 10.1093/jurban/jth094.
- Background: PubMed 22305807Ahnquist J, Wamala SP, Lindstrom M. Social determinants of health--a question of social or economic capital? Interaction effects of socioeconomic factors on health outcomes. Soc Sci Med. 2012 Mar;74(6):930-9. doi: 10.1016/j.socscimed.2011.11.026. Epub 2012 Jan 21.
- Background: PubMed 10432904Kawachi I, Kennedy BP, Glass R. Social capital and self-rated health: a contextual analysis. Am J Public Health. 1999 Aug;89(8):1187-93. doi: 10.2105/ajph.89.8.1187.
- Background: PubMed 23186534Nyqvist F, Forsman AK, Giuntoli G, Cattan M. Social capital as a resource for mental well-being in older people: a systematic review. Aging Ment Health. 2013;17(4):394-410. doi: 10.1080/13607863.2012.742490. Epub 2012 Nov 27.
- Derived from this study: PubMed 33413233Blancafort Alias S, Monteserin Nadal R, Moral I, Roque Figols M, Rojano I Luque X, Coll-Planas L. Promoting social capital, self-management and health literacy in older adults through a group-based intervention delivered in low-income urban areas: results of the randomized trial AEQUALIS. BMC Public Health. 2021 Jan 7;21(1):84. doi: 10.1186/s12889-020-10094-9.
- Derived from this study: PubMed 29534699Coll-Planas L, Blancafort S, Rojano X, Roque M, Monteserin R. Promoting self-management, health literacy and social capital to reduce health inequalities in older adults living in urban disadvantaged areas: protocol of the randomised controlled trial AEQUALIS. BMC Public Health. 2018 Mar 13;18(1):345. doi: 10.1186/s12889-018-5219-x.
- Individual participant dataSharing planned: No
Related trials for Health Status Disparities
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Not yet recruitingPhase 2/3
Diabetes Prevention Through Genetics, Familial History and Behavior Change
Prediabetes, Weight Loss
Active, not recruitingPhase 2
Determining the Optimal Amount of Structured Environments for Healthy Kids
Health Status Disparities, Pediatric Obesity
Active, not recruitingPhase 2
Healthy Kids Beyond the Bell: Investigating the Impact of After-School and Summer Programs
Health Status Disparities, Pediatric Obesity
Recruiting
Somatic Health Screening for Adults in Outpatient Psychiatric Care in Denmark (SomaScreen)
Atrial Fibrillation (AF), Heart Failure
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.
Laura Coll-Planas, MD principal investigator
Fundació Salut i Envelliment UAB
Sergi Blancafort, PhD principal investigator
Fundació Salut i Envelliment UAB
Rosa Monteserin, MD PhD principal investigator
Equipo Atencio Primaria Sardenya
Questions about this trial
What is this clinical trial studying?
A study testing Program "Sentirnos bien" (Feeling well) in people with Health Status Disparities and Subjective Health, run by Fundacio Salut i Envelliment UAB.
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 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-perceived health (time frame: at 3 months (just after the intervention)). 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 NCT02733523, which also lists 8 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 7 Feb 2018.