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Self-management, Health Literacy and Social Capital in Socioeconomically Disadvantaged Older Adults (AEQUALIS)

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ClinicalTrials.gov Identifier: NCT02733523
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
Recercaixa
Equip Atencio Primaria Sardenya
Information provided by (Responsible Party):
Laura Coll, Fundacio Salut i Envelliment UAB

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Health Status Disparities Subjective Health Self Care Social Capital Health Literacy Aging Behavioral: Program "Sentirnos bien" (Feeling well) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Literacy

Arm Intervention/treatment
Experimental: Program "Sentirnos bien"

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
Behavioral: 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.

No Intervention: Control arm
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).



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Self-perceived health [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Thermometer from 0-100

  2. Health related quality of life [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    12 items Short Form Survey from the RAND Medical Outcomes Study.

  3. Self-rated quality of life [ Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Thermometer from 0-100

  4. Loneliness [ Time Frame: t month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Scale Gierveld and De Jong

  5. Depressive symptoms [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Geriatric Depression Scale

  6. Physical activity [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    International Physical Activity Questionnaire (IPAQ)

  7. Short Physical Performance Battery [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Functional test that scores performance in three physical aspects: balance, strength and gait speed.

  8. Health service use [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Times attending primary and hospital health care

  9. Unintended effects [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Questions ad hoc to assess effects not intended by the intervention perceived negatively by the participant.

  10. Self-care / healthy habits [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Scale ASA (Appraisal of Self-Care Agency Scale)

  11. Health literacy [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    questions from the European Health Literacy Scale (HLS EU-16)

  12. Social capital [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    2 questions from the European Values Survey

  13. Social support [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Questionnaire "Inventario de recursos sociales en ancianos" from Díaz Veiga

  14. Social participation [ Time Frame: at month 3 (just after the intervention) and at month 12 (9 months after the intervention) ]
    Questionnaire "Escala Este II de Soledad - Índice de participación social subjetiva"



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733523


Sponsors and Collaborators
Fundacio Salut i Envelliment UAB
Recercaixa
Equip Atencio Primaria Sardenya
Investigators
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Principal Investigator: Laura Coll-Planas, MD Fundació Salut i Envelliment UAB
Principal Investigator: Sergi Blancafort, PhD Fundació Salut i Envelliment UAB
Principal Investigator: Rosa Monteserin, MD PhD Equipo Atencio Primaria Sardenya
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Laura Coll, MD, head of research on health and ageing, Fundacio Salut i Envelliment UAB
ClinicalTrials.gov Identifier: NCT02733523    
Other Study ID Numbers: FSIE-Recercaixa2014
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No