NCT02463734

Brief Summary

The purpose of this research is to develop the "DQoL-OC", a unique questionnaire to evaluate the quality of life of people aged 60 or above providing care for a family member with Alzheimer's disease or other related dementia at home in the UK. This questionnaire is aimed at allowing researchers, health and social professionals, as well as the older family carers themselves, to quantify the impact caring in different aspects life, for the purposes of economic evaluation or implementation and evaluation of interventions. The results from this study will also help us to understand better the aspects that affect carers' quality of life and well-being, which may guide future policies and the support provided to older family carers in the future. The DQoL-OC is being developed in two parts. The first part is now completed and was carried out through focus groups with older family carers for discussions about important aspects related to their quality of life and well-being in order to create the items of the new questionnaire. Its preliminary version contains 100 questions about the practical aspects of care and caregiving, carers' feelings and concerns and satisfaction with life and with the caring role. The second part of the DQoL-OC development is currently being carried out and aims to evaluate its validity and reliability for use with older family carers and to reduce it into a smaller number of items. About 300 older family carers are invited to answer individually the DQoL-OC and other similar questionnaires for these purposes. About 25 participants taking part in this study are invited to answer the same questions with an interval of two weeks in order to allow us to compare the results and its stability over this period of time.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Shorter than P25 for all trials

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

6 months

First QC Date

June 2, 2015

Last Update Submit

December 1, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life (HRQoL)

    Questionnaire

    8 months

Secondary Outcomes (3)

  • Health status

    8 months

  • Caring issues

    8 months

  • Socio-demographic data

    8 months

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Older family carers: To be an old person (between 60 and 100 years old), currently providing care for a family member with dementia (carers' self-report) at home in the UK, to understand and speak English, to accept to participate of the study

You may qualify if:

  • To be aged between 60 and 100 years old;
  • To be currently providing care for a family member with dementia (carers' -self-report) at home in the UK;
  • To speak and understand English;
  • To show an interest in participating in the research.

You may not qualify if:

  • To be aged under 60 years old or above 100 years old;
  • To provide paid care for the person with dementia;
  • Those with no familiar relationship with the person being cared for;
  • The family member with dementia is not being cared for at home;
  • The care is not provided in the UK;
  • The family member being cared for does not have dementia;
  • Do not speak or understand English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Clinical Commissioning Group - Nottingham North & East GP practices

Arnold, Nottinghamshire, NG5 6LU, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Mansfield and Ashfield Memory Assessment Service

Ashfield, Nottinghamshire, NG174JL, United Kingdom

RECRUITING

Clinical Commissioning Group - Newark and Sherwood GP practices

Balderton, Nottinghamshire, NG24 3HJ, United Kingdom

RECRUITING

Clinical Commissioning Group - Mansfield and Ashfield GP practices

Mansfield, Nottinghamshire, NG21 OHJ, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Newark and Sherwood Memory Assessment Service

Newark, Nottinghamshire, NG24 4DE, United Kingdom

RECRUITING

Clinical Commissioning Group - Bassetlaw GP practices

Nottingham, Nottinghamshire, DN22 7XF, United Kingdom

RECRUITING

Clinical Commissioning Group - Nottingham City GP practices

Nottingham, Nottinghamshire, NG1 6GN, United Kingdom

RECRUITING

Clinical Commissioning Group - Rushcliffe GP practices

Nottingham, Nottinghamshire, NG11 6LQ, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Rushcliffe Memory Assessment Service

Nottingham, Nottinghamshire, NG2 6PR, United Kingdom

RECRUITING

Community Mental Health Services for Older People - City Memory Assessment Service

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Gedling and Huckanall Memory Assessment Service

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Brostowe Memory Assessment Service

Nottingham, Nottinghamshire, NG9 8DB, United Kingdom

RECRUITING

Clinical Commissioning Group - Nottingham West GP practices

Stapleford, Nottinghamshire, NG9 8DB, United Kingdom

RECRUITING

Community Mental Health Services for Older People - Bassetlaw Memory Assessment Service

Worksop, Nottinghamshire, S810BD, United Kingdom

RECRUITING

Related Publications (29)

  • BARTLETT, M. S. 1954. A note on multiplying factors for various chi-squared approximations. Joural of the Royal Statistical Society, Series B, 296-298.

    BACKGROUND
  • Bleichrodt H, Johannesson M. An experimental test of a theoretical foundation for rating-scale valuations. Med Decis Making. 1997 Apr-Jun;17(2):208-16. doi: 10.1177/0272989X9701700212.

    PMID: 9107617BACKGROUND
  • de Boer AG, van Lanschot JJ, Stalmeier PF, van Sandick JW, Hulscher JB, de Haes JC, Sprangers MA. Is a single-item visual analogue scale as valid, reliable and responsive as multi-item scales in measuring quality of life? Qual Life Res. 2004 Mar;13(2):311-20. doi: 10.1023/B:QURE.0000018499.64574.1f.

    PMID: 15085903BACKGROUND
  • Caballero FF, Miret M, Power M, Chatterji S, Tobiasz-Adamczyk B, Koskinen S, Leonardi M, Olaya B, Haro JM, Ayuso-Mateos JL. Validation of an instrument to evaluate quality of life in the aging population: WHOQOL-AGE. Health Qual Life Outcomes. 2013 Oct 23;11:177. doi: 10.1186/1477-7525-11-177.

    PMID: 24152691BACKGROUND
  • Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain. 1983 May;16(1):87-101. doi: 10.1016/0304-3959(83)90088-X.

    PMID: 6602967BACKGROUND
  • COSTELLO, A. & OSBORNE, J. 2005. Best Practices in Exploratory Factor Analysis: Four Recommendations for Getting the Most From Your Analysis. Practical Assessment and Research Evaluation, 10, 1-9.

    BACKGROUND
  • CRESWELL, J. W. & CLARK, V. L. P. 2011. Designing and conducting mixed methods research, SAGE.

    BACKGROUND
  • Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

    PMID: 16367493BACKGROUND
  • DZIUBAN, C. D. & SHIRKEY, E. C. 1974. When is a correlation matrix appropriate for factor analysis? Some decision rules. Psychological Bulletin, 81, 358-361

    BACKGROUND
  • EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.

    PMID: 10109801BACKGROUND
  • FABRIGAR, L., WEGENER, D., MACCALLUM, R. & STRAHAN, E. 1999. Evaluating the use of exploratory factor analysis in psychological research. Psychological Methods, 4, 272-299

    BACKGROUND
  • KAISER, H. F. 1970. A second generation little jiffy. Psychometrika, 35, 401-415.

    BACKGROUND
  • KAISER HF, CAFFREY J. ALPHA FACTOR ANALYSIS. Psychometrika. 1965 Mar;30:1-14. doi: 10.1007/BF02289743. No abstract available.

    PMID: 14293189BACKGROUND
  • Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

    PMID: 843571BACKGROUND
  • Leung KF, Liu FB, Zhao L, Fang JQ, Chan K, Lin LZ. Development and validation of the Chinese Quality of Life Instrument. Health Qual Life Outcomes. 2005 Apr 16;3:26. doi: 10.1186/1477-7525-3-26.

    PMID: 15833138BACKGROUND
  • LUNDBERG, L., JOHANNESSON, M., ISACSON, D. G. L. & BORGQUIST, L. 1999. Health state utilities in a general population in relation to age, gender and socioeconomic factors. Eur J Pub Health, 9, 211-217.

    BACKGROUND
  • MACCALLUM, R., WIDAMAN, K., ZHANG, S. & HONG, S. 1999. Sample size in factor analysis. Psychological Methods, 4, 84-99.

    BACKGROUND
  • MUNDFROM, D., SHAW, D. & KE, T. 2005. Minimum Sample Size Recommendations for Conducting Factor Analyses. International Journal of Testing, 5, 159-168.

    BACKGROUND
  • Nagpal J, Kumar A, Kakar S, Bhartia A. The development of 'Quality of Life Instrument for Indian Diabetes patients (QOLID): a validation and reliability study in middle and higher income groups. J Assoc Physicians India. 2010 May;58:295-304.

    PMID: 21117348BACKGROUND
  • Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Res Nurs Health. 2006 Oct;29(5):489-97. doi: 10.1002/nur.20147.

    PMID: 16977646BACKGROUND
  • RUBIO, D. M., BERG-WEGER, M., TEBB, S. S., LEE, E. S. & RAUCH, S. 2003. Objectifying content validity: Conducting a content validity study in social work research. Social Work Research, 27, 94-104.

    BACKGROUND
  • Shmueli A. Subjective health status and health values in the general population. Med Decis Making. 1999 Apr-Jun;19(2):122-7. doi: 10.1177/0272989X9901900202.

    PMID: 10231074BACKGROUND
  • Shmueli A. The Visual Analog rating Scale of health-related quality of life: an examination of end-digit preferences. Health Qual Life Outcomes. 2005 Nov 14;3:71. doi: 10.1186/1477-7525-3-71.

    PMID: 16285884BACKGROUND
  • Sim J, Wright CC. The kappa statistic in reliability studies: use, interpretation, and sample size requirements. Phys Ther. 2005 Mar;85(3):257-68.

    PMID: 15733050BACKGROUND
  • STREINER, D. L. & NORMAN, G. R. 1995. Health measurement scales: a practical guide to their development and use, New York, Oxford University Press.

    BACKGROUND
  • TABACHNICK, B. G. & FIDELL, L. S. 1996. Using Multivariate Statistics New York, Harper & Row.

    BACKGROUND
  • TORRANCE, G. W. 1978. Social preferences for health states: an empirical evaluation of three measurement techniques. Socio-Economic Planning Sci, 10, 129-138.

    BACKGROUND
  • Wassef W, Bova C, Barton B, Hartigan C. Pancreatitis Quality of Life Instrument: Development of a new instrument. SAGE Open Med. 2014 Feb 3;2:2050312114520856. doi: 10.1177/2050312114520856. eCollection 2014.

    PMID: 26770703BACKGROUND
  • WEINMAN, J., WRIGHT, S. & JOHNSTON, M. 1995. Measures in health psychology: A user's portfolio. Windsor, UK: NFER-NELSON.

    BACKGROUND

Study Officials

  • Aimee Aubeeluck

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 4, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations